DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is in a simple, sans-serif font. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## DEC 1 3 2001 Mr. Robert Duffy Director of Product Development Pulse Metric, Inc. 11777 Sorrento Valley Road San Diego, CA 92121 Re: K013358 Trade Name: DynaPulse 5000A Mini (ABP) Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 12, 2001 Received: November 16, 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, Loddy Teell - Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Statement (US) Food and Drog Administration's Center Soc. Device | Fand Radio Jogical Health 510(k) Number: K013358 Device Name: DynaPulse 5000A Mini (ABP) Non-Invasive Blood .?ressure Monitor Indications for Use: The DynaPulse 5000A Mini (ABP) is indicated for trained medical rofessionals to operate on a patient at clinical settings to collect and measure blood pressure, pulse rate and pressure waveform information, including ambulatory monitoring. Concurrence Of CDRH, Office of Device Evaluation (ODE) | Prescription Use<br>(Per 21 CFR 801.109) | <span></span> | |------------------------------------------|---------------| |------------------------------------------|---------------| OR | Over-The-Counter-Use<br>(Optional Format 1-2-96) | <span></span> | |--------------------------------------------------|---------------| |--------------------------------------------------|---------------| Division of Cardiovascular & Respiratory Devices | 510(k) Number | R013358 | |---------------|---------| |---------------|---------|