MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR

K012310 · Health & Life Co., Ltd. · DXN · Aug 22, 2001 · Cardiovascular

Device Facts

• Record ID: K012310
• Device Name: MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
• Applicant: Health & Life Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 22, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel . The intended for use of this over-the-counter device is for age 16 and above.

Device Story

HL168D is an automatic non-invasive blood pressure (NIBP) monitor; utilizes oscillometric method to measure systolic/diastolic blood pressure and heart rate; input via cuff inflation/deflation; output displayed on integrated LCD panel; intended for over-the-counter use by patients aged 16 and older; device provides automated readings to assist in monitoring cardiovascular parameters; clinical utility involves routine blood pressure tracking.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oscillometric measurement principle; automatic cuff inflation/deflation; integrated LCD display; standalone device; intended for over-the-counter use.

Indications for Use

Indicated for individuals aged 16 and older for the automatic measurement of systolic and diastolic blood pressure and heart rate using the oscillometric method.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

AUG 2 2 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan Chen Health & Life Co., Ltd. 6F, No. 407, Chung Shan Road, Sec. 2 Chung Ho City Taipei Hsien TAIWAN R.O.C.

Re: K012310

Trade Name: HL168D Non-Invasive Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulatory Class: Class II (two) Product Code: 74 DXN Dated: June 29, 2001 Received: July 23, 2001

Dear Ms. Chen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce suice in also 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). You may, therefore, market the device, subject to the general controls Cosmetic Pro (110) - The general controls provisions of the Act include requirements for annual provisions of atives of atives, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Frediation I ipproval), while Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mopolwaiith the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might

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Page 2 - Ms. Susan Chen

have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

nes E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## KO12310 510(k) Number (if known) :

Device Name : Full Automatic (NIBP) Blood Pressure Monitor

Trade Name : HL168D

## Indications For Use

Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .

The intended for use of this over-the-counter device is for age 16 and above.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription USE ( ) (Per 21 CFR 801.109) OR

Over-The-Counter Use( √ ) ( Optional Format 1-2)

K012310
Division of Cardiovascular & Respiratory Devices
510(k) Number