(221 days)
No
The description focuses on the mechanical and electronic components of a compressor nebulizer and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is designed to operate a nebulizer kit for the production of medical aerosol to treat respiratory disorders, indicating a therapeutic purpose.
No
The device is a compressor nebulizer designed for the production of medical aerosol for respiratory disorders, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a hardware device (compressor nebulizer) with a membrane pump and battery, not a software-only device.
Based on the provided information, the GUS831 compressor nebulizer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to produce compressed air to operate a nebulizer kit for the production of medical aerosol for respiratory disorders. This is a therapeutic application, delivering medication to the patient's respiratory system.
- Device Description: The description details a device that generates compressed air to atomize liquid medication for inhalation. This is consistent with a drug delivery device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to examine specimens. The GUS831 operates in vivo (within the body) by delivering medication to the respiratory tract.
N/A
Intended Use / Indications for Use
GUS831 compressor nebulizer is designed for the production of compressed air to operate a nebulizer kit for the production of medical aerosol for respiratory disorders. The nebulizer kit is intended for multiple use by single patient for single medication. GUS831 compressor nebulizer is intended for domestic use with children from 5 years old, adolescent and adult patients and requires the order of a physician for medical use.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
GUS831 Compressor Nebulizer is a portable aerosol nebulizer electronically powered by an external power adapter and by an internal rechargeable lithium polymer battery. The compressed air, created by the membrane pump of the device, flows into the nebulizer container kit. The air pressure forced the liquid through the nozzle where it is atomized against a plate within the container. The device is equipped with a mouthpiece to easily delivery the medical aerosol.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth
Indicated Patient Age Range
children from 5 years old, adolescent and adult patients
Intended User / Care Setting
Domestic use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device Testing:
- Biocompatibility testing: Conducted in accordance with FDA Biocompatibility guidance, 2016 (Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process") and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Tests performed for K121969 clearance for mouthpiece and nebulizer bottle included Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10), Genotoxicity (ISO 10993-3), and Implantation (ISO 10993-6).
- Biocompatibility evaluation of breathing gas pathways: Conducted according to the ISO 18562 family of standard by an independent source. Testing included Volatile Organic Compound Analysis (VOCs), Emitted Particulate Gas Analysis (EPA PM2.5), and Leachables in condensate (metal ions and organic impurities).
- Aerosol Characterization: Conducted in accordance with the relevant sections of the CDRH Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH – 1993). The particle size distribution test via Cascade Impactor of GUS831 Compressor Nebulizer was performed in comparison to the predicate device K121969 with three drugs (Albuterol sulfate, Ipratropium bromide, Cromolyn sodium) for adult and pediatric conditions. Key results indicated "almost all the performance parameters of the two different nebulizers were statistically identical for adult conditions and substantially equivalent in the therapeutic amount of medication delivered for pediatric conditions. The measured differences raise no new safety and efficacy issues; therefore, device equivalence is proved."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Aerosol Characterization (Adult Conditions):
- Particle Size (MMAD):
- Albuterol Sulfate (2.5 mg/3 ml): Subject Device 2.64±0.35, Predicate Device 3.87±0.31
- Ipratropium Bromide (0.5 mg/2.5 ml): Subject Device 2.51±0.36, Predicate Device 3.37±0.46
- Cromolyn Sodium (20 mg/2.0 ml): Subject Device 2.64±0.34, Predicate Device 2.87±0.15
- Geometric Standard Deviation:
- Albuterol Sulfate (2.5 mg/3 ml): Subject Device 3.32±0.57, Predicate Device 3.77±0.48
- Ipratropium Bromide (0.5 mg/2.5 ml): Subject Device 3.59±0.48, Predicate Device 4.14±0.25
- Cromolyn Sodium (20 mg/2.0 ml): Subject Device 3.37±0.70, Predicate Device 3.70±0.55
- Total Dose Delivered (µg):
- Albuterol Sulfate (2.5 mg/3 ml): Subject Device 471±45, Predicate Device 514±55
- Ipratropium Bromide (0.5 mg/2.5 ml): Subject Device 91±9, Predicate Device 89±12
- Cromolyn Sodium (20 mg/2.0 ml): Subject Device 3286±383, Predicate Device 2772±441
- Total Respirable Dose (0.5-5 um) (µg):
- Albuterol Sulfate (2.5 mg/3 ml): Subject Device 263±38, Predicate Device 259±37
- Ipratropium Bromide (0.5 mg/2.5 ml): Subject Device 50±8, Predicate Device 42±5
- Cromolyn Sodium (20 mg/2.0 ml): Subject Device 1913±328, Predicate Device 1448±312
- Coarse Particle Dose (>4.7 um) (µg):
- Albuterol Sulfate (2.5 mg/3 ml): Subject Device 178±23, Predicate Device 253±38
- Ipratropium Bromide (0.5 mg/2.5 ml): Subject Device 35±6, Predicate Device 41±8
- Cromolyn Sodium (20 mg/2.0 ml): Subject Device 1268±316, Predicate Device 1143±106
- Fine Particle Dose (4.7 um) (µg):
- Albuterol Sulfate (2.5 mg/3 ml): Subject Device 576±36, Predicate Device 701±107
- Ipratropium Bromide (0.5 mg/2.5 ml): Subject Device 113±27, Predicate Device 152±8
- Cromolyn Sodium (20 mg/2.0 ml): Subject Device 2920±113, Predicate Device 4343±426
- Fine Particle Dose (
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
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May 1, 2020
Globalcare Medical Technology Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, Nanshan Medical device industrial park, Nanshan District Shenzhen, 518067 Cn
Re: K192633
Trade/Device Name: GUS831 Compressor Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: April 22, 2020 Received: April 27, 2020
Dear Kevin Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James J. Lee Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192633
Device Name GUS831 Compressor Nebulizer
GUS831 compressor nebulizer is designed for the production of compressed air to operate a nebulizer kit for the production of medical aerosol for respiratory disorders. The nebulizer kit is intended for multiple use by single patient for single medication. GUS831 compressor nebulizer is intended for domestic use with children from 5 years old, adolescent and adult patients and requires the order of a physician for medical use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2020/02/02
1. Submission sponsor
Name: Globalcare Medical Technology Co., Ltd. Address: 7th Building, 39 Middle Industrial Main Road, European Industrial Zone, Xiaolan Town, Zhongshan City, Guangdong Province, P.R. China Contact person: Janice Deng Title: Regulatory Officer E-mail: janice@globalcare.com.cn Tel: +86 760 22589901-608
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: No. A415, Block A, NanShan Medical devices Industrial Park Nanshan District, Shenzhen,
Guangdong, P.R. China 518067
Contact person: Kevin Wang
E-mail: kevin@chonconn.com
Tel: +86-755 33941160
| Trade/Device Name | Compressor Nebulizer |
|---|---|
| Model | GUS831 |
| Common Name | Compressor Nebulizer |
| Regulatory Class | Class II |
| Classification | 21CFR §868.5630 / Nebulizer / CAF |
| Submission type | Traditional 510(K) |
Subject Device Information 3.
4. Predicate Device
By submission of the Traditional 510(k), Globalcare Medical Technology Co., Ltd. is requesting clearance for Compressor Nebulizer. It is comparable to the following legally marketed system: 1. TaiDoc Technology Corporation, U-RIGHT Compressor Nebulizer under K121969.
The subject device has same intended use, same target patient population, same performance effectiveness, performance safety as the predicate devices and no question is raised regarding to effectiveness and safety. So, the conclusion is that the subject device is substantial equivalent to the predicate.
5. Intended use & Indication for use
GUS831 compressor nebulizer is designed for the production of compressed air to operate a nebulizer kit for the production of medical aerosol for respiratory disorders. The nebulizer kit is intended for multiple use by single patient for single medication. GUS831 compressor nebulizer is intended for domestic use with children from 5 years old, adolescent and adult patients and requires the order of a physician for medical use.
Device Description 6.
GUS831 Compressor Nebulizer is a portable aerosol nebulizer electronically powered by an external power
4
adapter and by an internal rechargeable lithium polymer battery. The compressed air, created by the membrane pump of the device, flows into the nebulizer container kit. The air pressure forced the liquid through the nozzle where it is atomized against a plate within the container. The device is equipped with a mouthpiece to easily delivery the medical aerosol.
7. Principle of Operation
This device operates on the Venturi principle. Compressed air is driven through a converging nozzle, where it accelerates and emerges at a high velocity, creating a vacuum (Venturi effect). The vacuum draws a liquid residing in a reservoir up through a cylindrical channel and into the emerging airstream formed by the nozzle, to mix with air and impact upon a rigid surface. This process uses energy from the airstream to convert liquid into small droplets called aerosol. Upon reaching the user aerosol is suitably refined to enter the lungs effectively.
Comparison to the Predicate Device 8.
The GUS831 Compressor Nebulizer and U-RIGHT Compressor Nebulizer (K121969), are identical in purpose, function, core technology and method of operation. Only minor differences exist between the GUS831 Compressor Nebulizer and predicate, which do not affect the safety or effectiveness of the subject device. Table 1 provides a comparison of the subject and predicate devices.
| Features | Subject Device
GUS831 Compressor Nebulizer | Predicate Device
U-RIGHT Compressor Nebulizer | Comment |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| K number | K192633 | K121969 | / |
| Indication for use | GUS831 compressor nebulizer is
designed for the production of
compressed air to operate a
nebulizer kit for the production of
medical aerosol for respiratory
disorders. The nebulizer kit is
intended for multiple use by single
patient for single medication.
GUS831 compressor nebulizer is
intended for domestic use with
children from 5 years old,
adolescent and adult patients and
requires the order of a physician for
medical use. | U-RIGHT Compressor Nebulizer,
model TD-7013/TD-7012, is
designed to provide a compressed
air source to aerosolize
physician-prescribed liquid
medication when used in
combination with the packaged
Nebulizer kit, except for
Pentamidine. The packaged
Nebulizer kit is intended for single
use by single patient. U-RIGHT
Compressor Nebulizer, model
TD-7013/TD-7012, is intended for
use with children, adolescents (5
years to 18 years old), and adult
patients in the homecare settings. | Substantially
equivalent |
| Product Code | CAF | CAF | Same |
| Regulation
number | 21 CFR §868.5630 | 21 CFR §868.5630 | Same |
| Panel | Anesthesiology | Anesthesiology | Same |
| Class | Class II | Class II | Same |
| Use | Prescription Use | Prescription Use | Same |
| Features | Subject Device
GUS831 Compressor Nebulizer | Predicate Device
U-RIGHT Compressor Nebulizer | Comment |
| Target
Population | >5
years old | >2 years old | Same |
| Environmental
Use | Home use | Homecare setting | Same |
| Principle of
Operation | Compressor Air | Compressor Air | Same |
| Power source | DC adaptor: 5Vd.c.,
Internal lithium polymer (Li-Pol)
battery: 3.7Vd.c., 2570 mAh | DC adaptor: 6Vd.c. | Substantially
equivalent |
| Power
consumption | 10W | 6W | Difference has no
effect on safety or
effectiveness |
| Compressor
pressure range
(only compressor) | 13 ~ 17 psi | 15 ~ 17 psi | Difference has no
effect on safety or
effectiveness |
| Operating
pressure range
(with nebulizing
chamber) | 5.1 ~ 8 psi | 6 ~ 8 psi | Difference has no
effect on safety or
effectiveness |
| Flow Rate | 4 ~ 6 LPM | 4 LPM Max. | Substantially
equivalent |
| Noise Level | 45 dBA | 60 dBA | Difference has no
effect on safety or
effectiveness |
| Mode of
operation | 30 mins on/ 30 mins off | 30 mins on/ 30 mins off | Same |
| Nebulization
Rate (avg) | 0.25 ml/min | 0.25ml/min | Same |
| Medication
capacity | 2ml ~ 6ml | 2ml ~ 6ml | Same |
| User interface | On/Off switch
LED indicators | On/Off switch | Difference has no
effect on safety or
effectiveness |
| Standards met | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11 | IEC 60601-1
IEC 60601-1-2 | Subject device
complies with
more recent
standards |
| Patient contact /
anatomical site | Mouth | Mouth | Same |
| Contact materials
per
ISO 10993-1 | External communicating
components with tissue contact | External communicating
components with tissue contact | Same |
| Features | Subject Device
GUS831 Compressor Nebulizer | Predicate Device
U-RIGHT Compressor Nebulizer | Comment |
| Biocompatibility
testing | Cytotoxicity (ISO 10993-5)
Irritation (ISO 10993-10)
Sensitization (ISO 10993-10)
Implantation (ISO 10993-6)
Genotoxicity (ISO 10993-3)
Gas pathways ISO 18562 | Cytotoxicity (ISO 10993-5)
Irritation (ISO 10993-10)
Sensitization (ISO 10993-10)
Implantation (ISO 10993-6)
Genotoxicity (ISO 10993-3) | Subject device
complies with
more recent
standards |
| Dimensions (mm) | 68x45x110 | 125x115x46 | Difference has no
effect on safety or
effectiveness |
| Weight (Kg) | 0.250 | 0.290 | Difference has no
effect on safety or
effectiveness |
| Operating
conditions | 10-40°C
10-95% RH
700-1060 hPa | 10-40°C
30-85% RH
700-1060 hPa | Difference has no
effect on safety or
effectiveness |
| Storage
conditions | -20-60°C
10-95% RH
700-1060 hPa | -25-70°C
10-95% RH
700-1060 hPa | Difference has no
effect on safety or
effectiveness |
| Materials | Case: ABS
Medicine chamber: PC
Nozzle: PP
Mouthpiece: HDPE
Air tube: PVC | Case: ABS
Medicine chamber: PC
Nozzle: PP
Mouthpiece: HDPE
Air tube: PVC | Same |
| Sterility | No | No | Same |
| Reusable parts | Nebulizing chamber and
mouthpiece
Compressor and air tube | Compressor and air tube | Difference has no
effect on safety or
effectiveness |
| Device Cleaning | Compressor: Soft dry cloth and
non-abrasive cleaners for the outer
case of the compressor
Kit: wash with soap and hot water
after each treatment | Compressor: Alcohol cotton swabs
for the outer casing of the compressor
Kit: wash with running water or soak
in warm water | Difference has no
effect on safety or
effectiveness |
| Contraindications | None | Pentamidine | Difference has no
effect on safety or
effectiveness |
| Device lifetime | 400 hours running time | 3 years | Difference has no
effect on safety or
effectiveness |
| Features | Drug | Subject Device
GUS831 | Predicate Device
U-RIGHT |
| Particle Characterization per Cascade Impactor @ 28 LPM | | | |
| Particle Size (MMAD) | Albuterol Sulfate (2.5 mg/3 ml) | 2.64±0.35 | 3.87±0.31 |
Table 1: Comparison to Predicate Device
5
6
9. Device Testing
Testing and equivalence analysis were performed to support the substantial equivalence determination.
9.1 Biocompatibility testing
The biocompatibility evaluation for the GUS831 compressor nebulizer was conducted in accordance with the FDA Biocompatibility guidance, 2016 (Use of International Standard ISO 10993-1, "Biological
7
evaluation of medical devices - Part 1: Evaluation and testing within a risk management process") and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
All the patient-contacting parts of the GUS831 compressor nebulizer are:
Device: External Communicating (Indirect gas pathway) Tissue / Bone / Dentin communicating
Duration of Use - permanent (> 30 days)
Mouthpiece: Surface Contact Mucosal membrane
Duration of Use - permanent (> 30 days)
The GUS compressor nebulizer use an identical nebulizing kit to U-RIGHT TD-7013, which is already cleared under K121969. Mouthpiece and nebulizing bottle have same formulation and processing, and no other chemicals have been added (e.g., plasticizers, fillers, cleaning agents, mold, release agents etc.) so new issue regarding biological safety are not raised.
Mouthpiece and nebulizer bottle tests were performed for K121969 clearance as external communicating components with tissue contact:
- Cytotoxicity (ISO 10993-5) .
- . Sensitization (ISO 10993-10)
- . Irritation (ISO 10993-10)
- . Genotoxicity (ISO 10993-3)
- Implantation (ISO 10993-6) .
9.2 Biocompatibility evaluation of breathing gas pathways
Additional testing pertaining to the gas pathway and associated risk assessments/conclusions were conducted according to the ISO 18562 family of standard by an independent source. Testing included the following assessments:
- . Volatile Organic Compound Analysis (VOCs)
- Emitted Particulate Gas Analysis (EPA PM2.5) .
- . Leachables in condensate (metal ions and organic impurities)
9.3 Aerosol Characterization
Aerosol characterization testing for the subject device and predicate device was conducted in accordance with the relevant sections of the CDRH Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH – 1993). The particle size distribution test via Cascade Impactor of GUS831 Compressor Nebulizer was performed in comparison to the predicate device K121969 with three drugs (Albuterol sulfate, Ipratropium bromide, Cromolyn sodium). The test has shown almost all the performance parameters of the two different nebulizers were statistically identical for adult conditions and substantially equivalent in the therapeutic amount of medication delivered for pediatric conditions. The measured differences raise no new safety and efficacy issues; therefore, device equivalence is proved.
ADULT CONDITIONS:
8
| (μm) | Ipratropium Bromide (0.5 mg/2.5 ml) | 2.51±0.36 | 3.37±0.46 |
|---|---|---|---|
| Cromolyn Sodium (20 mg/2.0 ml) | 2.64±0.34 | 2.87±0.15 | |
| Geometric Standard Deviation | Albuterol Sulfate (2.5 mg/3 ml) | 3.32±0.57 | 3.77±0.48 |
| Ipratropium Bromide (0.5 mg/2.5 ml) | 3.59±0.48 | 4.14±0.25 | |
| Cromolyn Sodium (20 mg/2.0 ml) | 3.37±0.70 | 3.70±0.55 | |
| Total Dose Delivered | Albuterol Sulfate (2.5 mg/3 ml) | 471±45 | 514±55 |
| (µg) | Ipratropium Bromide (0.5 mg/2.5 ml) | 91±9 | 89±12 |
| Cromolyn Sodium (20 mg/2.0 ml) | 3286±383 | 2772±441 | |
| Total Respirable Dose (0.5-5 um) | Albuterol Sulfate (2.5 mg/3 ml) | 263±38 | 259±37 |
| (µg) | Ipratropium Bromide (0.5 mg/2.5 ml) | 50±8 | 42±5 |
| Cromolyn Sodium (20 mg/2.0 ml) | 1913±328 | 1448±312 | |
| Coarse Particle Dose (>4.7 um) | Albuterol Sulfate (2.5 mg/3 ml) | 178±23 | 253±38 |
| (µg) | Ipratropium Bromide (0.5 mg/2.5 ml) | 35±6 | 41±8 |
| Cromolyn Sodium (20 mg/2.0 ml) | 1268±316 | 1143±106 | |
| Fine Particle Dose (4.7 um) | |||
| (µg) | Albuterol Sulfate (2.5 mg/3 ml) | 576±36 | 701±107 |
| Ipratropium Bromide (0.5 mg/2.5 ml) | 113±27 | 152±8 | |
| Cromolyn Sodium (20 mg/2.0 ml) | 2920±113 | 4343±426 | |
| Fine Particle Dose ( |