RI-MEGA

K972377 · Rudolf Riester GmbH & Co. KG · DXQ · Sep 24, 1997 · Cardiovascular

Device Facts

• Record ID: K972377
• Device Name: RI-MEGA
• 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

Ri-Mega is a sphygmomanometer and is intended to measure the blood pressure

Device Story

RI-Mega is a sphygmomanometer used to measure blood pressure. Device operates as a manual or automated blood pressure monitoring system. Used by healthcare professionals or patients in clinical or home settings to obtain systolic and diastolic pressure readings. Output provides blood pressure values to assist in cardiovascular health assessment and clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence determined via 510(k) regulatory pathway.

Technological Characteristics

Sphygmomanometer for blood pressure measurement. Specific materials, energy sources, and software details not provided in the document.

Indications for Use

Indicated for the measurement of blood pressure in patients.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern 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

Re: K972377 RI-MEGA Requlatory 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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 Reqister. 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 requlations.

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## 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html."

Sincerely yours,

Thomas f. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_K972377

Device Name: RI-Mega

Indications For Use:

Ri-Mega is a sphygmomanometer and is intended to measure the blood pressure

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Dee Campbell

Division Sign-Off) (Division Sign-Oir)
Division of Cardiovascular, Respiratory, Divisionrological Devices 510(k) Number_KazZ377

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)