(69 days)
K0110865, K964332
Not Found
No
The description details a standard steam sterilizer with factory-programmed cycles and a microprocessor controller for basic safeguards. There is no mention of AI, ML, or any adaptive or learning capabilities.
No
The device is a sterilizer for heat and moisture-stable materials used in healthcare facilities, not a device that treats a disease or condition in a patient.
No
This device is a sterilizer for medical instruments and materials, not a diagnostic device. It is used to prepare items for use, not to diagnose a condition or disease.
No
The device description clearly states it is a "Steam Sterilizer" and describes physical components and functions related to sterilization, which are hardware-based. While it includes a "microprocessor controller," this is part of the overall hardware system, not a standalone software-only device.
Based on the provided information, the Belimed Steam Sterilizer TOP 5000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as "sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities." This is a process to render medical devices and materials sterile, not to perform tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The device is described as a "Class II medical device as defined by 21 CFR §880.6880." This classification is for sterilizers, not IVD devices.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on the effectiveness of the sterilization process (killing microorganisms, achieving specific temperature and time parameters), which is relevant to a sterilizer, not an IVD device.
In summary, the Belimed Steam Sterilizer TOP 5000 is a medical device used for sterilizing other medical devices and materials, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Belimed Steam Sterilizer TOP 5000 is intended for the terminal sterilization of heat and moisture-stable materials in healthcare facilities.
The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The Belimed Steam Sterilizer TOP 5000 is a Class II medical device as defined by 21 CFR §880.6880. The Belimed Steam Sterilizer TOP 5000 is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1)
The Belimed Steam Sterilizer TOP 5000 is offered in the following medium-size configurations:
26″x 42.5″x 41″ (660 mm x 1080 mm x 1040 mm) Single Door, Prevacuum
26″x 42.5″x 41″ (660 mm x 1080 mm x 1040 mm) Double Door, Prevacuum
26"x 42.5″x 55″ (660 mm x 1080 mm x 1400mm) Single Door, Prevacuum
26"x 42.5"x 55" (660 mm x 1080 mm x 1400mm) Double Door. Prevacuum
26"x 42.5"x 67" (660 mm x 1080 mm x 1700mm) Single Door, Prevacuum
26"x 42.5"x 67" (660 mm x 1080 mm x 1700mm) Double Door, Prevacuum
26"x 42.5"x 79″ (660 mm x 1080 mm x 2000mm) Single Door, Prevacuum
26"x 42.5″x 79″ (660 mm x 1080 mm x 2000mm) Double Door, Prevacuum
26"x 48.5"x 43" (660 mm x 1230 mm x 1100mm) Single Door, Floor Flush Design, Prevacuum
26″x 48.5″x 43″ (660 mm x 1230 mm x 1100mm) Double Door, Floor Flush Design, Prevacuum
26″x 48.5″x 55″ (660 mm x 1230 mm x 1400mm) Single Door, Floor Flush Design, Prevacuum
26"x 48.5″x 55″ (660 mm x 1230 mm x 1400mm) Double Door, Floor Flush Design, Prevacuum
26"x 48.5"x 67″ (660 mm x 1230 mm x 1700mm) Single Door, Floor Flush Design, Prevacuum
26"x 48.5"x 67″ (660 mm x 1230 mm x 1700mm) Double Door, Floor Flush Design, Prevacuum
26″x 48.5″x 79″ (660 mm x 1230 mm x 2000mm) Single Door, Floor Flush Design, Prevacuum
26″x 48.5″x 79″ (660 mm x 1230 mm x 2000mm) Double Door, Floor Flush Design, Prevacuum
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities
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)
Efficacy of sterilizer function and exposure time recommendations ate ultimately shown by complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10° reduction. SAUTER AG validates its sterilization cycles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI). Prior to release, the Belimed Steam Sterilizer TOP 5000 will be validated to meet the requirements of AAMI/ANSI-ST8, Third Edition, January 1994.
The results of the Belimed Sterilizer TOP 5000 verification studies demonstrate that the sterilizer performs as intended and are summarized as follows:
- All PREVAC cycles verified using the fabric test pack, as described in Section 5.5.1 AAMI/ANSI-. ST8 were qualified according to section 5.5.1 AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10* through achievement of a time-at-temperature sufficient to produce an FO of at least 12 by 1/2 cycle, a moisture retention of less than 3% increase in presterilization test pack weight, and exhibited no wet spots.
- All PREVAC cycles verified using full load instruments trays were qualified according to section . 5.5.3 of AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an FO of at least 12 by 1½ cycle, a moisture retention of less than 20% increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper.
- All FLASH cycles verified using the unwrapped instrument tray were qualified according to section t 7.7.3 AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an FO of at least 12 by 1/2 cycle and exhibited no wet spots.
- All LIQUID cycles verified using three 1'000 ml flasks, as described in section 5.5.2.1 of . AAMI/ANSI-ST8, were qualified according to section 5.5.2 of AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10th through achievement of a time-attemperature sufficient to produce an FO of at least 12 by ½ cycle, a water loss not exceeding 50 ml, and automatic sealing of the flask closure. A temperature of 121°C was achieved and maintained in the center of the liquid for at least 12 minutes.
- The BD cycle was verified using the Bowie-Dick Test Pack were qualified according to section 5.6 . of AAMI/ANSI-ST8, and demonstrated a uniform color change throughout the test sheet.
- . The software validation for the cycle operation was performed according to FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Pre-market Submissions for Software Contained in Medical Devices (5/29/98)".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sterility assurance level (SAL) of at least 10° reduction
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K0110865, K964332
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).
0
JUN 2 6 2002
510(k) SUMMARY
Submitter Information.
Hans Stadler SAUTER AG Head of product development Zelgstrasse 8 CH-8583 Sulgen/ Switzerland +41 71 644 85 97 Date Summary Prepared: July 9, 2001
Introduction
The Belimed Steam Sterilizer TOP 5000 is a Class II medical device as defined by 21 CFR §880.6880. The Belimed Steam Sterilizer TOP 5000 is substantially equivalent to the predicate devices, the Amsco Century Medium Steam Sterilizer, K0110865 and Amsco Steam Sterilizer K964332.
The Belimed Steam Sterilizer TOP 5000 is intended for the terminal sterilization of heat and moisturestable materials in healthcare facilities.
The Belimed Steam Sterilizer TOP 5000 is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1)
| CYCLES | STERILIZE
TEMP | STERILIZE
TIME | DRY TIME | RECOMMENDED LOAD |
|---------------------------|-------------------|-------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------|
| PREVAC
270° F (132°C) | 270° F
(132°C) | 4 minutes | 20 minutes | Double-wrapped Instrument Trays, max.
weight of 17 lbs (7.7 kg) each. Fabric packs.
Refer to Table 2 for recommended quantities. |
| PREVAC
270° F (132°C) | 270° F
(132°C) | 4 minutes | 5 minutes | Fabric Packs.
Refer to Table 2 for recommended quantities. |
| LIQUID
250° F (121°C) | 250° F
(121°C) | 45 minutes | - | Refer to Table 3 for Guidelines |
| EXPRESS
270° F (132°C) | 270° F
(132°C) | 4 minutes | 3 minutes | Single Wrapped Instrument Tray with non
porous single instrument |
| FLASH
270° F (132°C) | 270° F
(132°C) | 3 minutes | 1 minute | Unwrapped Instrument Tray with a single
Instrument |
| FLASH
270° F (132°C) | 270° F
(132°C) | 10 minutes | 1 minute | Unwrapped Instrument Tray with non porous
multiple instruments (max. weight of 17 lbs) |
Table 1: Factory programmed sterilization cycles
1
| Table 2 : Recommended Loads | |||
|---|---|---|---|
| Sterilizer Chamber Size | (mm) Wrapped Instrument | ||
| Trays 20"x10" | |||
| max. 17lb each | Fabric Packs | ||
| 11"x11"x9" | |||
| max. 6.6lb each | Fabric Packs | ||
| 23"x11"x11" | |||
| max. 17lb each | |||
| 26"x 42.5"x 41" (660 x 1080 x 1040) | 9 | 18 | 9 |
| 26"x 42.5"x 55" (660 x 1080 x 1400) | 12 | 30 | 12 |
| 26"x 42.5"x 67" (660 x 1080 x 1700) | 15 | 36 | 15 |
| 26"x 42.5"x 79" (660 x 1080 x 2000) | 18 | 42 | 18 |
| 26"x 48.5"x 43" (660 x 1230 x 1100) | 9 | 18 | 9 |
| 26"x 48.5"x 55" (660 x 1230 x 1400) | 12 | 30 | 12 |
| 26"x 48.5"x 67" (660 x 1230 x 1700) | 15 | 36 | 15 |
| 26"x 48.5"x 79" (660 x 1230 x 2000) | 18 | 42 | 18 |
The following table (Table 2) is SAUTER's recommended loads by sterilizer chamber size:
The following table (Table 3) is SAUTER AG's Guidelines for liquid cycle processing: Table 3: Guidelines for liquid 250°F cycle processing
| Sterilizer Chamber Size | (mm) | Volume of Liquid in One Container | Number of containers |
|---|---|---|---|
| 26"x 42.5"x 41" (660 x 1080 x 1040) | 1000 ml | 126 | |
| 26"x 42.5"x 55" (660 x 1080 x 1400) | 1000 ml | 168 | |
| 26"x 42.5"x 67" (660 x 1080 x 1700) | 1000 ml | 210 | |
| 26"x 42.5"x 79" (660 x 1080 x 2000) | 1000 ml | 252 | |
| 26"x 48.5"x 43" (660 x 1230 x 1100) | 1000 ml | 126 | |
| 26"x 48.5"x 55" (660 x 1230 x 1400) | 1000 ml | 168 | |
| 26"x 48.5"x 67" (660 x 1230 x 1700) | 1000 ml | 210 | |
| 26"x 48.5"x 79" (660 x 1230 x 2000) | 1000 ml | 252 |
Effectiveness
Efficacy of sterilizer function and exposure time recommendations ate ultimately shown by complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10° reduction. SAUTER AG validates its sterilization cycles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI). Prior to release, the Belimed Steam Sterilizer TOP 5000 will be validated to meet the requirements of AAMI/ANSI-ST8, Third Edition, January 1994.
2
The results of the Belimed Sterilizer TOP 5000 verification studies demonstrate that the sterilizer performs as intended and are summarized as follows:
- All PREVAC cycles verified using the fabric test pack, as described in Section 5.5.1 AAMI/ANSI-. ST8 were qualified according to section 5.5.1 AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10* through achievement of a time-at-temperature sufficient to produce an FO of at least 12 by 1/2 cycle, a moisture retention of less than 3% increase in presterilization test pack weight, and exhibited no wet spots.
- All PREVAC cycles verified using full load instruments trays were qualified according to section . 5.5.3 of AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an FO of at least 12 by 1½ cycle, a moisture retention of less than 20% increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper.
- All FLASH cycles verified using the unwrapped instrument tray were qualified according to section t 7.7.3 AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an FO of at least 12 by 1/2 cycle and exhibited no wet spots.
- All LIQUID cycles verified using three 1'000 ml flasks, as described in section 5.5.2.1 of . AAMI/ANSI-ST8, were qualified according to section 5.5.2 of AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10th through achievement of a time-attemperature sufficient to produce an FO of at least 12 by ½ cycle, a water loss not exceeding 50 ml, and automatic sealing of the flask closure. A temperature of 121°C was achieved and maintained in the center of the liquid for at least 12 minutes.
- The BD cycle was verified using the Bowie-Dick Test Pack were qualified according to section 5.6 . of AAMI/ANSI-ST8, and demonstrated a uniform color change throughout the test sheet.
- . The software validation for the cycle operation was performed according to FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Pre-market Submissions for Software Contained in Medical Devices (5/29/98)".
Safety
SAUTER AG sterilizers including the Belimed Steam Sterilizer TOP 5000 have been designed. constructed and tested to meet the safety and performance requirements of various national safety codes and standards. The Belimed Steam Sterilizer TOP 5000 will comply with the following requirements:
- ينهنجي جي Underwriter Laboratory (UL) Code 3101-1
-
- Canadian Standards Association (CSA) Standard C22.2 No. 1010-1 (IEC1010-1)
3
- American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired 3. pressure vessels
Hazards-Failure of Performances
Failure of the sterilization process can lead to incidence of cross contamination, the transmission of potentially infectious organisms from one infected person to another who was not otherwise infected prior to the incident.
To avoid failure, the user must ensure the materials, instruments and devices to be sterilized are thoroughly cleaned, that the manufacturer's instructions for use are followed., that the cycle to be used for each type of sterilizer load has been validated, that the sterilizer has been maintained in accordance with the sterilizer's manufacturer's maintenance schedule and is operating properly, and that each sterilizer load is monitored with available and validated biological and chemical sterilization process indicators.
Today, there are many steam sterilizers in daily use in hospitals throughout the United States. The incident of sterilizer malfunction or sterilization process failure is relatively rare considering the wide spread use of steam sterilizers. Further, there are no known reports in the literature of patient infection that have resulted from steam sterilizer failure. The technology designed in Belimed Steam Sterilizer TOP 5000 provides microprocessor controller safequards that aborts the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs.
User information
SAUTER AG provides information to the user that is intended to insure safe and effective use of steam sterilization in its detailed Operator's Manual and other labeling. SAUTER AG also recommends the use and periodic review of the AAMI steam sterilization standards to ensure further assurance of the safe and effective use of steam sterilization equipment in health care facilities.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three parallel, curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2002
Sauter AG C/O Mr. Mark Job Responsible Third Party Official TUV America, Incorporated 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
Re: K021223
Trade/Device Name: Belimed Steam Sterilizer, Model Top 5000 Regulation Number: 880.6880 Regulation Name: Stream Sterilizer Regulatory Class: II Product Code: FLE Dated: May 10, 2002 Received: June 12, 2002
Dear Mr. Job:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
5
Page 2 - Mr. Job
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Tin othy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
6
INDICATIONS FOR USE STATEMENT DEVICE NAME: BELIMED STEAM STERILIZER TOP 5000
INDICATIONS FOR USE:
The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.
The Belimed Steam Sterilizer TOP 5000 is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1)
| CYCLES | STERILIZE TEMP | STERILIZE TIME | DRY TIME | RECOMMENDED LOAD |
|---|---|---|---|---|
| PREVAC | ||||
| 270° F (132°C) | 270° F | |||
| (132°C) | 4 minutes | 20 minutes | Double-wrapped Instrument Trays, max. | |
| weight of 17 lbs (7.7 kg) each. Fabric packs. | ||||
| Refer to Table 2 for recommended quantities. | ||||
| PREVAC | ||||
| 270° F (132°C) | 270° F | |||
| (132°C) | 4 minutes | 5 minutes | Fabric Packs. | |
| LIQUID | ||||
| 250° F (121°C) | 250° F | |||
| (121°C) | 45 minutes | 0 minute | Refer to Table 3 for Guidelines | |
| EXPRESS | ||||
| 270° F (132°C) | 270° F | |||
| (132°C) | 4 minutes | 3 minutes | Single Wrapped Instrument Tray with non porous single instrument | |
| FLASH | ||||
| 270° F (132°C) | 270° F | |||
| (132°C) | 3 minutes | 1 minute | Unwrapped Instrument Tray with a single Instrument | |
| FLASH | ||||
| 270° F (132°C) | 270° F | |||
| (132°C) | 10 minutes | 1 minute | Unwrapped Instrument Tray with non porous multiple instruments (max. weight of 17 lbs) |
Table 1: Factory programmed Sterilization Cycles
7
| Table 2: Recommended Loads | |||
|---|---|---|---|
| Sterilizer Chamber Size | |||
| (mm) | Wrapped Instrument | ||
| Trays 20"x10" | |||
| max. 17lb each | Fabric Packs | ||
| 11"x11"x9" | |||
| max. 6.6lb each | Fabric Packs | ||
| 23"x11"x11" | |||
| max. 17lb each | |||
| 26"x 42.5"x 41" (660 x 1080 x 1040) | 9 | 18 | 9 |
| 26"x 42.5"x 55" (660 x 1080 x 1400) | 12 | 30 | 12 |
| 26"x 42.5"x 67" (660 x 1080 x 1700) | 15 | 36 | 15 |
| 26"x 42.5"x 79" (660 x 1080 x 2000) | 18 | 42 | 18 |
| 26"x 48.5"x 43" (660 x 1230 x 1100) | 9 | 18 | 9 |
| 26"x 48.5"x 55" (660 x 1230 x 1400) | 12 | 30 | 12 |
| 26"x 48.5"x 67" (660 x 1230 x 1700) | 15 | 36 | 15 |
| 26"x 48.5"x 79" (660 x 1230 x 2000) | 18 | 42 | 18 |
· The following table (Table 2) is SAUTER's recommended loads by sterilizer size:
The following table (Table 3) is SAUTER AG's Guidelines for liquid cycle processing:
| Sterilizer Chamber Size | (mm) | Volume of Liquid in One
Container | Number of containers |
|-------------------------------------|------|--------------------------------------|----------------------|
| 26"x 42.5"x 41" (660 x 1080 x 1040) | | 1000 ml | 126 |
| 26"x 42.5"x 55" (660 x 1080 x 1400) | | 1000 ml | 168 |
| 26"x 42.5"x 67" (660 x 1080 x 1700) | | 1000 ml | 210 |
| 26"x 42.5"x 79" (660 x 1080 x 2000) | | 1000 ml | 252 |
| 26"x 48.5"x 43" (660 x 1230 x 1100) | | 1000 ml | 126 |
| 26"x 48.5"x 55" (660 x 1230 x 1400) | | 1000 ml | 168 |
| 26"x 48.5"x 67" (660 x 1230 x 1700) | | 1000 ml | 210 |
| 26"x 48.5"x 79" (660 x 1230 x 2000) | | 1000 ml | 252 |
Table 3: Guidelines for liquid cycle processing
8
The Belimed Steam Sterilizer TOP 5000 is offered in the following medium-size configurations:
26″x 42.5″x 41″ (660 mm x 1080 mm x 1040 mm) 26″x 42.5″x 41″ (660 mm x 1080 mm x 1040 mm) 26"x 42.5″x 55″ (660 mm x 1080 mm x 1400mm) 26"x 42.5"x 55" (660 mm x 1080 mm x 1400mm) 26"x 42.5"x 67" (660 mm x 1080 mm x 1700mm) 26"x 42.5"x 67" (660 mm x 1080 mm x 1700mm) 26"x 42.5"x 79″ (660 mm x 1080 mm x 2000mm) 26"x 42.5″x 79″ (660 mm x 1080 mm x 2000mm) 26"x 48.5"x 43" (660 mm x 1230 mm x 1100mm) 26″x 48.5″x 43″ (660 mm x 1230 mm x 1100mm) 26″x 48.5″x 55″ (660 mm x 1230 mm x 1400mm) 26"x 48.5″x 55″ (660 mm x 1230 mm x 1400mm) 26"x 48.5"x 67″ (660 mm x 1230 mm x 1700mm) 26"x 48.5"x 67″ (660 mm x 1230 mm x 1700mm) 26″x 48.5″x 79″ (660 mm x 1230 mm x 2000mm) 26″x 48.5″x 79″ (660 mm x 1230 mm x 2000mm)
Single Door, Prevacuum Double Door, Prevacuum Single Door, Prevacuum Double Door. Prevacuum Single Door, Prevacuum Double Door, Prevacuum Single Door, Prevacuum Double Door, Prevacuum Single Door, Floor Flush Design, Prevacuum Double Door, Floor Flush Design, Prevacuum Single Door, Floor Flush Design, Prevacuum Double Door, Floor Flush Design, Prevacuum Single Door, Floor Flush Design, Prevacuum Double Door, Floor Flush Design, Prevacuum Single Door, Floor Flush Design, Prevacuum Double Door, Floor Flush Design, Prevacuum
(Division Sign-Off)
Division of D
on Control eral Hospital Device
510(k) Number K02122