SANAPHON N

K972378 · Rudolf Riester GmbH & Co. KG · DXQ · Sep 24, 1997 · Cardiovascular

Device Facts

• Record ID: K972378
• Device Name: SANAPHON N
• Applicant: Rudolf Riester GmbH & Co. KG
• Product Code: DXQ · Cardiovascular
• Decision Date: Sep 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2

Intended Use

Sanaphon-N is a sphygmomanometer and is intended to measure the blood pressure (self-meaurement)

Device Story

Sanaphon-N is a sphygmomanometer used for self-measurement of blood pressure. Device operates as a manual blood pressure monitoring tool. User inflates cuff and listens for Korotkoff sounds via integrated stethoscope to determine systolic and diastolic pressure values. Used in home settings by patients for personal health monitoring. Output consists of visual pressure readings from gauge, interpreted by user to track blood pressure levels. Facilitates patient self-management of hypertension or general cardiovascular health monitoring.

Clinical Evidence

No clinical data provided; device is a standard manual sphygmomanometer.

Technological Characteristics

Manual sphygmomanometer consisting of an inflatable cuff, pressure gauge, and stethoscope. Mechanical operation; no electronic components, software, or algorithms.

Indications for Use

Indicated for individuals performing self-measurement of blood pressure.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Ms. Patricia Riester-Freudenmann Rudolf Riester GmbH & CO. KG P.O. Box 35 Bruckstraße 31 D-72417 Jungingen, Germany

SEP 2 4 1997

K972378 Re: SanaPhon-N Regulatory Class: Class II (Two) Product Code: DXQ Dated: June 13, 1997 Received: June 26, 1997

Dear Ms. Riester-Freudenmann:

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 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 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.

{1}------------------------------------------------

## Page 2 - Ms. Patricia Riester-Freudenmann

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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on vour 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/dsmamain.html."

Sincerely yours,

Thomas J. Callahan, Ph.D.

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

Enclosure

{2}------------------------------------------------

Page 1 of 1

510(k) Number (if known): K972378

Device Name: Sanaphon-N

Indications For Use:

门

DXC

Sanaphon-N is a sphygmomanometer and is intended to measure the blood pressure (self-meaurement)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Belle Lampert

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

X 97 510(k) Number_

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use √

(Optional Format 1-2-96)