(197 days)
Measure blood pressure (systolic and diastolic) and pulse rate.
Not Found
This document is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving a device meets them. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested information based on the provided text.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health, featuring a staff with two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2002
Mr. Jerry P. Wang Director of Engineering & QA A & D Engineering, Inc. 1555 McCandless Dr. Milpitas, CA 95035
Re: K012472
Trade Name: A & D Medical Lifesource UA-787, UA-787H, UA-787V, UA-787PC, and UA-787T Digital Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: 74 DXN Dated: November 16, 2001 Received: November 19, 2001
Dear Mr. Wang:
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 for associated in the encreated 976, the enactment date of the Medical Device Amendments, or to conniner of First to File) 2011-07-12, in accordance with the provisions of the Federal Food, DDI (A do noos that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , ateres, mains 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 If your device 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. Jerry P. Wang
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase oc advised that I Driv issualited our device complies with other requirements of the Act that I Dr Has Internes and regulations administered by other Federal agencies. You must of any I coleral statutes and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rord in and quind) of the revisions (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 premailed predicated 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 11 you declie specific art 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Far 3646. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-461 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 Oinci general 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,
K. Quin Till
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}------------------------------------------------
510(k) Number (if known): __ K O | 2 4 7 2
Device Name: A&D Medical LifeSource UA-787, UA-787H, UA-787V, UA-787V, UA-787PC, & UA-787T Digital Blood Pressure Monitors
Indications for Use:
Measure blood pressure (systolic and diastolic) and pulse rate.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | K02472 |
|---|---|
| --------------- | -------- |
| Prescription Use | or | Over-The-Counter Use X |
|---|---|---|
| ------------------ | ---- | -------------------------- |
(Optional Format 1-2-96)
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).