DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 0 1 2001 Mr. Robert Duffy Director of Product Development Pulse Metric, Inc. 11777 Sorrento Valley Rd. San Diego, CA 92121 Re: K012498 Trade Name: DynaPulse Model DP500G Non-Invasive Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system. Regulatory Class: II (two) Product Code: DXN Dated: August 2, 2001 Received: August 3, 2001 Dear Mr. Duffy: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Mr. Robert Duffy Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Qaki Mellum James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## NOV 01 2001 ## Indications for Use Statement ## (US) Foodrand Drug Administrations Center for Devices and Radiological Health, 510(k) Number: K012498 Device Name: DynaPulse 500G (DP500G) Non-Invasive Blood Pressure Monitor Indications for Use: The DynaPulse 500G is indicated for trained medical professionals to operate on partient at clinical settings to collect and measure blood pressure, pulser and pressure waveform information. In and willing to collined willing to collined willing to collined willing to col sellings to concer and measure probles, problems at home who are capable and willing to selfaddition, the Dyllar uise 2000 is marcated to purchase week on the device does not send any administrate this device upon present and experience are required to check and interpret the information delivered. 11777 Sorrento Valley Rd., San Diego, CA 92121 USA • Tel: (858)480-1171 • Fax: (858) 480-1147 **Prescription Use** (Per 21 CFR 801.109) Division of Cardiovascular & Respiratory Devices 510(k) Number K012498