ABN ANEROID SPHYGMOMANOMETER

K012444 · Pt. Sugih Instrumendo Abadi · DXQ · Aug 16, 2001 · Cardiovascular

Device Facts

• Record ID: K012444
• Device Name: ABN ANEROID SPHYGMOMANOMETER
• Applicant: Pt. Sugih Instrumendo Abadi
• Product Code: DXQ · Cardiovascular
• Decision Date: Aug 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure blood pressure by means of a manually inflatable cuff and a manometer analog gauge. These devices will be used by physicians, nurses, paramedics and retail consumers.

Device Story

ABN Aneroid Sphygmomanometer is a manual, non-invasive blood pressure measurement device. It consists of a manually inflatable cuff and an analog manometer gauge. Operated by physicians, nurses, paramedics, or retail consumers, the device functions by inflating the cuff to occlude blood flow and using the gauge to monitor pressure during deflation. The healthcare provider or user observes the gauge to determine systolic and diastolic blood pressure values. This manual process assists in clinical decision-making regarding cardiovascular health and hypertension management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual aneroid sphygmomanometer consisting of an inflatable cuff and an analog manometer gauge. Non-electronic, mechanical device. No software or energy source required.

Indications for Use

Indicated for non-invasive blood pressure measurement in patients. Intended for use by physicians, nurses, paramedics, and retail consumers.

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2001

PT. Sugih Instrumento Abadi c/o Mr. Pat Paladino Intertek Testing Services 70 Codman Hill Road Boxborough, MA 01719

Re: K012444 Trade Name: ABN Aneroid Sphygmomanometer Regulation Number: 21 CFR 870.1120 Regulatory Class: Class II (two) Product Code: 78 DXQ Dated: July 31, 2001 Received: August 1, 2001

Dear Mr. Paladino:

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 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). 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 (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. Pat Paladino

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 additionally 607.10 for questions on the promotion and advertising of your device, (301) 59 m 40 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 mormation on your respeat its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

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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## INDICATIONS FOR USE

510(K) Number:_

K012444

ABN Aneroid Sphygmomanometers Device Name: Indications for Use:

An Aneroid Sphygmomanometer is a non-invasive medical device intended to An Anerold Sphygmomanometer to a non-mans of a manually inflatable cuff and a manometer analog gauge.

These devices will be used by physicians, nurses, paramedics and retail consumers.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109

(Optional Format 3-10-98)

933A Motor Parkway, Hauppauge, NY 11788 Tech-Med Services, Inc. Fax: [phone] Tel: [phone] www.tech-medservices.com