MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR

K050039 · Mars Medical Products · DXN · Mar 25, 2005 · Cardiovascular

Device Facts

• Record ID: K050039
• Device Name: MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR
• Applicant: Mars Medical Products
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The device is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the Oscillometric method. The device also measure pulse rate. The device is for adult use only. The device is for use at home or while traveling.

Device Story

MS-930 Mars Inflate-Read Blood Pressure Monitor; noninvasive oscillometric device. Inputs: pressure signals from cuff inflation/deflation. Processing: oscillometric algorithm derives systolic/diastolic blood pressure and pulse rate. Output: digital display of blood pressure and pulse rate. Usage: home or travel; patient self-use. Benefit: enables convenient, periodic blood pressure monitoring for adults.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Noninvasive blood pressure measurement system; oscillometric sensing principle; digital display; intended for adult use; home/travel form factor.

Indications for Use

Indicated for adult patients for the noninvasive measurement of systolic and diastolic blood pressure and pulse rate using the oscillometric method. Intended for home or travel use. Over-the-counter use.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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MAR 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mars Medical Products c/o Mr. E. J. Smith Smith Associates P.O. Box 4341 Crofton, MD 21114

Re: K050039

K050039
Trade Name: MS-930 Mars Inflate-Read Blood Pressure Monitor
11-11-11-11-11-11-11-11-2011-11-11 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: February 21, 2005 Received: February 23, 2005

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(ts) premaint is substantially equivalent (for the indications
referenced above and have determined the device is substantials; in interstate referenced above and have determined the devices marketed in interstate for use stated in the encrosule) to regally mances promotical Device Ameral ments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chactinene with the provisions of the Federal Food. Drug, devices that have been recuire approval of a proval of a proval application (PMA).
and Cosmetic Act (Act) that do not require approval estaurations of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, seejoer of the Securements for annual registration, listing of
general controls provisions of the Act include requirements for annual r general controls provisions of the Fet merade requires.
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 if your device is classified (sec above) nils Existing major regulations affecting your device can
may be subject to such additional controls. Box may be subject to such additional controls. Existing may organts 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Peachartergening your device in the Federal Register.

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Page 2 -- Mr. E. J. Smith

Please be advised that FDA's issuance of a substantial equivalence determination are not mean Please be advised fill I DA s issualled of a success complies with other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decormmancis an administered by other Federal agencies. You must light or any Federal Statutes and regulations daminders but not limited to: registration and listing (21 comply with an the Act s requirements, mercedes, and manufacturing practice requirements as set CFK Part 807), labeling (21 CFRT art 820); and If applicable, the electronic forth in the quanty systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control provisions (Doctions on 2 evice as described in your Section 510(k) I his felter will anow you to oegin maneting your antial equivalence of your device to a legally premarket notification. The PDF miding of castination 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), please If you desire specific advice ion your don'te en earline of the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note of Compli contact the Office of Compullion at (210) = if = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Missionaling by reference to premaixevitibilities under the Act from the Division of Small other general information on your respensed its toll-free number [phone] or Manufacturers, International and Goless http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bhimima for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 05003

## INDICATIONS FOR USE

| Applicant: | Mars Medical Products Co., Ltd. |
|------------|---------------------------------|
|------------|---------------------------------|

K050039 510(k) Number (if known): ___

Device Name: MS-930 Mars Inflate-Read Blood Pressure Monitor

## Indications For Use:

- 1. The device is designed to provide signals from which systolic and diastolic pressures can be The device also measure pulse rate. derived through the use of the Oscillometric method.
- 2. The device is for adult use only.
- The device is for use at home or while traveling. 3.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over the Counter Use X__

For FDA Use Only

B.J. Simmon

ivision Sign-Off) Division of Cardlovascular Devices 510(k) Number 050039