DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP

K010828 · A&D Engineering, Inc. · DXN · Mar 29, 2001 · Cardiovascular

Device Facts

• Record ID: K010828
• Device Name: DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP
• Applicant: A&D Engineering, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The A&D Medical LifeSource TM-2655, TM-2655P & TM-2655VP are designed to measure blood pressure (systolic and diastolic) and pulse rate in adult patients with arm circumferences from 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).

Device Story

Digital blood pressure monitors (TM-2655, TM-2655P, TM-2655VP) for clinical or home use; oscillometric measurement principle; input via arm cuff; output of systolic/diastolic blood pressure and pulse rate on integrated display; TM-2655P/VP models include integrated printer for output documentation; intended for adult population; assists healthcare providers or patients in monitoring cardiovascular status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oscillometric blood pressure measurement; accommodates arm circumferences 13.0-45.0 cm; digital display; TM-2655P/VP models feature integrated thermal printer; standalone operation.

Indications for Use

Indicated for adult patients with arm circumferences 13.0 cm to 45.0 cm for the measurement of systolic/diastolic blood pressure and pulse rate.

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2001

A & D Engineering Inc. c/o Mr. Robert Mosenkis Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298

Re: K010828

Trade Name: Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VP Regulatory Class: II (two) Product Code: DXN Dated: March 19, 2001 Received: March 20, 2001

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce stated in the energismere to regarly maxical Device Amendments, or to devices that prior to rid) 20, 1978, accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Sourisions 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 (Premarket Approval), 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 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 comply with 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

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#### Page 2 - Mr. Robert Mosenkis

response to your premarket notification submission does not affect any obligation you might 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 Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Hypt Rhodes

James 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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# 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

## Device Name: A&D Medical LifeSource TM-2655, TM-2655P & TM-2655VP Digital Blood Pressure Monitors

### Indications for Use:

The A&D Medical LifeSource TM-2655, TM-2655P & TM-2655VP are designed to The A&D Mcdroal Dirocodice 11:2 & systolic) and pulse rate in adult patients with arm measure brood probare (shares 1 inches (13.0 cm) to 17.7 inches (45.0 cm).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Hyat Qude

Division Of Cardiovascular & Respiratory Devices
510(k) Number K010828

Prescription Use

Or

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ X

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