(15 days)
An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure blood pressure by means of a manually inflatable cuff and a manometer analog gauge. These devices will be used by physicians, nurses, paramedics and retail consumers.
An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure blood pressure by means of a manually inflatable cuff and a manometer analog gauge.
The provided text is a 510(k) Pre-Market Notification from the FDA concerning an ABN Aneroid Sphygmomanometer. This document is a regulatory approval for the device based on its substantial equivalence to a legally marketed predicate device.
It does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily states:
- The device's trade name: ABN Aneroid Sphygmomanometer
- Its regulation number: 21 CFR 870.1120
- Its regulatory class: Class II (two)
- Its product code: 78 DXQ
- The date of receipt and approval.
- The FDA's determination of substantial equivalence to a predicate device.
- Indications for Use: "An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure the blood pressure of a patient by means of a manually inflatable cuff and a manometer analog gauge. These devices will be used by physicians, nurses, paramedics and retail consumers."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. This type of information would typically be found in a separate study report or a detailed technical submission, not in this specific FDA approval letter.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2001
PT. Sugih Instrumento Abadi c/o Mr. Pat Paladino Intertek Testing Services 70 Codman Hill Road Boxborough, MA 01719
Re: K012444 Trade Name: ABN Aneroid Sphygmomanometer Regulation Number: 21 CFR 870.1120 Regulatory Class: Class II (two) Product Code: 78 DXQ Dated: July 31, 2001 Received: August 1, 2001
Dear Mr. Paladino:
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 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). 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 to 895. A substantially equivalent determination assumes compliance 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 Register. Please note: this
{1}------------------------------------------------
Page 2 - Mr. Pat Paladino
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.
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 additionally 607.10 for questions on the promotion and advertising of your device, (301) 59 m 40 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your respeat 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,
James E. Dillard III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
e source for ical diagnostic equipment and undry products
Page 1 of 1
INDICATIONS FOR USE
510(K) Number:_
ABN Aneroid Sphygmomanometers Device Name: Indications for Use:
An Aneroid Sphygmomanometer is a non-invasive medical device intended to An Anerold Sphygmomanometer to a non-mans of a manually inflatable cuff and a manometer analog gauge.
These devices will be used by physicians, nurses, paramedics and retail consumers.
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109
(Optional Format 3-10-98)
933A Motor Parkway, Hauppauge, NY 11788 Tech-Med Services, Inc. Fax: (631) 582 7321 Tel: (631) 582 7320 www.tech-medservices.com
§ 870.1120 Blood pressure cuff.
(a)
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.(b)
Classification. Class II (performance standards).