K Number
K170605
Device Name
Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D
Date Cleared
2018-03-27

(391 days)

Product Code
Regulation Number
870.1130
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia).
Device Description
The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillation mensuration. The series will automatically starting to take measurements after the inflation of the cuff finished, the results will show the systolic pressure and diastolic pressure and pulse rate. The monitor will store the measurements automatically, which including the time, date, blood pressure and pulse. The record could be revisited. Total 74 sets of data could be stored for YE670A, 60 sets of data for YE670D, 60 sets of data for YE650A, 80 sets of data for YE650D and 74 sets of data for YE660B.
More Information

No
The description details standard oscillometric blood pressure measurement and data storage, with no mention of AI or ML algorithms for analysis, interpretation, or prediction.

No
The device is intended to measure blood pressure and pulse rate, not to treat a condition.

Yes
Explanation: The device measures blood pressure and pulse rate, which are physiological parameters used to assess a person's health status and can indicate the presence of certain medical conditions. This function aligns with the definition of a diagnostic device, which is used to identify or monitor diseases or health conditions.

No

The device description explicitly mentions hardware components like a cuff and a monitor that performs inflation and measurement. It is not solely software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
  • Device Function: The description clearly states that this device is an electronic blood pressure monitor that measures blood pressure and pulse rate. This is a direct measurement of physiological parameters within the living body (in vivo).
  • Lack of Sample Analysis: The description does not mention any analysis of biological samples. The device directly interacts with the patient's arm to obtain the measurements.

Therefore, based on the provided information, this device falls under the category of a non-IVD medical device.

N/A

Intended Use / Indications for Use

Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia).

Product codes

DXN

Device Description

The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillation mensuration. The series will automatically starting to take measurements after the inflation of the cuff finished, the results will show the systolic pressure and diastolic pressure and pulse rate. The monitor will store the measurements automatically, which including the time, date, blood pressure and pulse. The record could be revisited. Total 74 sets of data could be stored for YE670A, 60 sets of data for YE670D, 60 sets of data for YE650A, 80 sets of data for YE650D and 74 sets of data for YE660B.

YE670series, YE650series and YE660B utilize modular design method, It consists of nine main modules: power-on self-test module, system initialization module, sampling data processing and pressure, pulse rate calculation module, display processing module, power detection processing module, data storage module, key scanning processing module, sampling processing module, voice broadcast processing module, and each module communicates through a message queue.

The blood pressure monitor controls the pneumatic flow control module through single-chipped microcomputer to pressurize the cuff module in order to exceed the lower pressure of patients, the blood being pushed against the artery walls; Pneumatic Flow Control Module being directed to release the pressure, while the pressure detection module collect pulse pressure signal and amplify filter; amplified filter signal being read by single-chipped microcomputer for pressure and pulse signal, through unique algorithm to obtain the systolic and diastolic pressure with pulse; Single-chipped microcomputer will control the inflation/deflation module to release the pressure after receive measurements; in the meanwhile, display the measurements results then stored the values with memory module.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper Arm

Indicated Patient Age Range

Adult (Not suitable for neonate, pregnancy or pre-eclampsia).

Intended User / Care Setting

household or medical center.

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)

Performance: ANSI/AAMI/ISO 81060-2 IEC 80601-2-30

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K133383

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 27, 2018

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Rong Zhong Quality Assurance Yunyang Industrial Park Danyang, Jiangsu, China 212300

Re: K170605

Trade/Device Name: Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 11, 2018 Received: February 26, 2018

Dear Rong Zhong:

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. 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 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); good

1

manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

M.A. Willhelmme

for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K170605

Device Name

Upper Arm Type Electronic Blood Pressure Monitor Series Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D

Indications for Use (Describe)

Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia).

Type of Use (Select one or both, as applicable)Over-The-Counter Use (21 CFR 201.66)
---------------------------------------------------------------------------------------

_ | Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/2 description: The image shows the word "yuwell" in red font. The font is bold and slightly italicized. The word is written in lowercase letters.

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)

    1. Date Prepared [21 CFR 807.92(a)(1)] 01/11/2018

2. Submitter's Information [21 CFR 807.92(a)(1)]

Company Name:Jiangsu Yuyue Medical Equipment& Supply Co., Ltd
Company Address:Yunyang Industrial Park, Danyang, Jiangsu, China
Contact Person:Rui, Li
Phone:0511-86900827
Fax:0511-86900991
Email:Lirui@yuyue.com.cn

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

| Trade Name: | Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood
Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Electronic Blood Pressure Monitor Series |
| Product Code: | DXN |
| Regulation Number: | 870.1130 |
| Device Class: | II |

4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[

The identification of predicates within this submission is as follow:

Predicate IOMRON Healthcare (China) Co., Ltd.
Manufacturer:
Trade Name:Model HEM-7320
Common Name:Noninvasive Blood PressureMeasurement System
Product Code:DXN
Classification Name:Noninvasive blood pressure measurement
Regulation Number:21CFR 870.1130
Classification:Class II
FDA 510 (k) #:K133383
    1. Description of the Device [21 CFR 807.92(a)(4)]

SECTION 7 - 2 of 5

4

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Image /page/4/Picture/2 description: The image shows the word "yuwell" in red font. The font is sans-serif and appears to be bolded. The word is slightly blurred, suggesting the image may be a close-up or a lower-resolution file.

The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillation mensuration. The series will automatically starting to take measurements after the inflation of the cuff finished, the results will show the systolic pressure and diastolic pressure and pulse rate. The monitor will store the measurements automatically, which including the time, date, blood pressure and pulse. The record could be revisited. Total 74 sets of data could be stored for YE670A, 60 sets of data for YE670D, 60 sets of data for YE650A, 80 sets of data for YE650D and 74 sets of data for YE660B.

6. Intended Use [21 CFR 807.92(a)(5)]

Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia).

7. Technological Characteristic [21 CFR 807.92(a)(6)]

YE670series, YE650series and YE660B utilize modular design method, It consists of nine main modules: power-on self-test module, system initialization module, sampling data processing and pressure, pulse rate calculation module, display processing module, power detection processing module, data storage module, key scanning processing module, sampling processing module, voice broadcast processing module, and each module communicates through a message queue.

The blood pressure monitor controls the pneumatic flow control module through single-chipped microcomputer to pressurize the cuff module in order to exceed the lower pressure of patients, the blood being pushed against the artery walls; Pneumatic Flow Control Module being directed to release the pressure, while the pressure detection module collect pulse pressure signal and amplify filter; amplified filter signal being read by single-chipped microcomputer for pressure and pulse signal, through unique algorithm to obtain the systolic and diastolic pressure with pulse; Single-chipped microcomputer will control the inflation/deflation module to release the pressure after receive measurements; in the meanwhile, display the measurements results then stored the values with memory module.

SECTION 7 - 3 of 5

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Image /page/5/Picture/1 description: The image shows the text "K170605" in the upper left corner. Below this text is the word "yuwell" in a stylized, red font. The word is slightly blurred, giving it a sense of motion or depth. A black line is at the bottom of the image.

8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]

Table 1YE650AYE650DYE670AYE670DYE660BPredicate Device
Product CodeDXNDXNDXNDXNDXNDXN
Regulation No.870.1130870.1130870.1130870.1130870.1130870.1130
ClassificationIIIIIIIIIIII
Intended UseElectronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia)Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia)Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia)Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia)Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia)The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
510 (k) NumberN/AN/AN/AN/AN/AK133383
Design MethodOscillometric MethodOscillometric MethodOscillometric MethodOscillometric MethodOscillometric MethodOscillometric Method

SECTION 7 - 1 of 5

6

IIIIIe

| Patient

PopulationAdultAdultAdultAdultAdultAdult
Measurement
SiteUpper ArmUpper ArmUpper ArmUpper ArmUpper ArmUpper Arm
Cuff
Circumference220mm ~ 320mm220mm ~ 320mm220mm ~ 320mm220mm ~ 320mm220mm ~ 320mm220mm ~420mm
Inflation
MethodAutomatic by
electronic pumpAutomatic by
electronic pumpAutomatic by
electronic pumpAutomatic by
electronic pumpAutomatic by
electronic pumpAutomatic by
electronic pump
Deflation
MethodAutomatic Pressure
Release ValveAutomatic Pressure
Release ValveAutomatic Pressure
Release ValveAutomatic Pressure
Release ValveAutomatic Pressure
Release ValveAutomatic Pressure
Release Valve
DisplayLCD Digital DisplayBacklight LCD
Digital DisplayLCD Digital DisplayLCD Digital DisplayLCD Digital DisplayLCD Display
Patients
Contacting
MaterialsPatient contact
materials of the cuff
have been tested in
accordance with ISO
10993 and FDA
guidance.Patient contact
materials of the cuff
have been tested in
accordance with ISO
10993 and FDA
guidance.Patient contact
materials of the cuff
have been tested in
accordance with ISO
10993 and FDA
guidance.Patient contact
materials of the cuff
have been tested in
accordance with ISO
10993 and FDA
guidance.Patient contact
materials of the cuff
have been tested in
accordance with ISO
10993 and FDA
guidance.Patient contact
material of the cuff
have been tested in
accordance with ISO
10993 and FDA
guidance.
Memory SizeUp to 60sets of dataUp to 80 sets of dataUp to 74 sets of dataUp to 60 sets of dataUp to 74 sets of dataUp to 100 sets of
data
Measurement
Pressure Range0 ~ 280 mmHg (0
kPa ~ 37.3 kPa)0~280 mmHg (0
kPa ~ 37.3 kPa)0 ~ 280 mmHg (0
kPa ~ 37.3 kPa)0 ~ 280 mmHg (0
kPa ~ 37.3 kPa)0~280mmHg (0-
37.3kPa)0 mmHg ~ 299
mmHg(0 kPa~ 39.9
kPa)
Range Accuracy士3 mmHg
(±0.4kPa)士3 mmHg
(±0.4kPa)±3 mmHg
(±0.4kPa)士3 mmHg
(±0.4kPa)士3mmHg
(±0.4kPa)土3mmHg
(±0.4kPa)or 2% of
reading
Measurement
Pulse Range40 ~ 200 beats/min40 ~ 200 beats/min40 ~ 200 beats/min40 ~ 200 beats/min40 ~ 200 beats/min40 ~ 180 beats/min
Pulse Accuracy±5% of reading
value土5% of reading
value±5% of reading
value±5% of reading
value土5% of reading
valueWithin ±5%of
reading
Pressurization
SourceAutomatic
PressurizeAutomatic
PressurizeAutomatic
PressurizeAutomatic
PressurizeAutomatic
PressurizeAutomatic Internal
Pump
Pressure SensorSemiconductor
Pressure SensorSemiconductor
Pressure SensorSemiconductor
Pressure SensorSemiconductor
Pressure SensorSemiconductor
Pressure SensorSemiconductor
Pressure Sensor
Operating
EnvironmentTemperature: +10 °C
~ +40 °C
Humidity: 15% RH
~ 90% RH(no
condensation)Temperature: +10 °C
~ +40 °C
Humidity: 15% RH
~ 90% RH(no
condensation)Temperature: +10 °C
~ +40 °C
Humidity: 15% RH
~ 90% RH(no
condensation)Temperature: +10 °C
~ +40 °C
Humidity: 15% RH
~ 90% RH(no
condensation)Temperature: +10 °C
~ +40 °C
Humidity: 15% RH
~ 90% RH(no
condensation)Temperature: +10 °C (50-104 °F)
Humidity: 30% RH
~ 85% RH(no
condensation)
Storage
EnvironmentTemperature: -20 °C
~ +55 °C
Humidity: 15% RH
~ 90% RH(no
condensation)Temperature: -20 °C
~ +55 °C
Humidity: 15% RH
~ 90% RH(no
condensation)Temperature: -20 °C
~ +55 °C
Humidity: 15% RH
~ 90% RH(no
condensation)Temperature: -20 °C
~ +55 °C
Humidity: 15% RH
~ 90% RH(no
condensation)Temperature: -20 °C
~ +55 °C
Humidity: 15% RH
~ 90% RH(no
condensation)Temperature: -20 °C
~ +60 °C
Humidity: 10% RH
~ 95% RH(no
condensation)
Energy Source4 AA batteries4 AA batteries4 AA batteries4 AA batteries4 AA batteries4 AA batteries or
AC Adapter
Display ContentCuff Pressure, Pulse,
Date,
Time,
Systolic/Diastolic
Pressure, error
message,
measurements
results in memory,
Irregular Heart Beat
Feature, Body
movement detection
Cuff Wrapping
DetectionCuff Pressure, Pulse,
Date,
Time,
Systolic/Diastolic
Pressure, error
message,
measurements
results in memory,
Irregular Heart Beat
Feature, Body
movement detection
Cuff Wrapping
DetectionCuff Pressure, Pulse,
Date,
Time,
Systolic/Diastolic
Pressure, error
message,
measurements
results in memory,
Irregular Heart Beat
Feature, Body
movement detection
Cuff Wrapping
DetectionCuff Pressure, Pulse,
Date,
Time,
Systolic/Diastolic
Pressure, error
message,
measurements
results in memory,
Irregular Heart Beat
Feature, Body
movement detection
Cuff Wrapping
DetectionCuff Pressure, pulse,
Systolic/Diastolic,
error message,
measurement results
in the memory, Date,
Time.Cuff Pressure,
Systolic/Diastolic
Pressure, pulse rate,
error message,
measurement results
in the memory
ControlsSET Button,
Plus/Minus Button,
START/PULSE
ButtonSET Button,
Plus/Minus Button,
START/PULSE
ButtonSET Button,
Memory Button,
START/PULSE
ButtonSET Button,
Memory Button,
START/PULSE
ButtonMemory Button,
Start ButtonSTART/STOP
button, Date/Tim
Setting Button,
UP/DOWN Button,
USER ID Selections
Button
PerformanceANSI/AAMI/ISO
81060-2
IEC
80601-2-30ANSI/AAMI/ISO
81060-2
IEC
80601-2-30ANSI/AAMI/ISO
81060-2
IEC
80601-2-30ANSI/AAMI/ISO
81060-2
IEC
80601-2-30ANSI/AAMI/ISO
81060-2
IEC
80601-2-30ANSI/AAMI/ISO
81060-2
IEC
80601-2-30

SECTION 7 - 2 of 5

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SECTION 7 - 3 of 5

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| Biocompatibility | ISO 10993-1, FDA
Guidance, Tests
included
Cytotoxicity,
Sensitization and
Intracutaneous
Reactivity | ISO 10993-1, FDA
Guidance, Tests
included
Cytotoxicity,
Sensitization and
Intracutaneous
Reactivity | ISO 10993-1, FDA
Guidance, Tests
included
Cytotoxicity,
Sensitization and
Intracutaneous
Reactivity | ISO 10993-1, FDA
Guidance, Tests
included
Cytotoxicity,
Sensitization and
Intracutaneous
Reactivity | ISO 10993-1, FDA
Guidance, Tests
included
Cytotoxicity,
Sensitization and
Intracutaneous
Reactivity | ISO 10993-1, FDA
Guidance, Tests
included
Cytotoxicity,
Sensitization and
Intracutaneous
Reactivity |
|-------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | IEC
60601-1 | IEC
60601-1 | IEC
60601-1 | IEC
60601-1 | IEC
60601-1 | IEC
60601-1 |
| EMC | IEC
60601-1-2 | IEC
60601-1-2 | IEC
60601-1-2 | IEC
60601-1-2 | IEC
60601-1-2 | IEC
60601-1-2 |
| Home Use | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 |

9

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Image /page/9/Picture/2 description: The image shows the word "yuwell" in red font. The font is bold and slightly italicized. The word is on a white background.

9. Conclusion [21 CFR 807.92(b)(3)]

The Upper Arm Type Electronic Blood Pressure Monitor650A, 650D, 670A, 670D and 660B are substantially equivalent to predicate device because both devices use identical technology and same intended use, also testing standards are identical with the predicates. The differences between both devices are insignificant in terms of safety and effectiveness.

SECTION 7 - 5 of 5