(118 days)
The Zefon blood pressure cuff is a reusable device to be used in conjunction with non-invasive automatic blood pressure monitors or non-invasive manual blood pressure measurement systems.
Not Found
This document is a 510(k) clearance letter for the Zefon DuraCheck Blood Pressure Cuffs. It indicates that the device has been found substantially equivalent to a predicate device. However, it does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert evaluations.
Therefore, based solely on the provided text, I cannot answer any of the questions regarding acceptance criteria, study details, and performance. The document focuses on regulatory clearance, not performance data.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2008
Zefon International c/o Mr. Scott Ryan, President 5350 SW 1st Lane Ocala, FL 34474
Re: K080366
Trade/Device Name: DuraCheck Blood Pressure Cuffs, ZDC4000 Series, with Sizes: Child, Small Adult, Adult, Large Adult and Thigh. Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (Two) Product Code: DXO Dated: May 7, 2008 Received: May 8, 2008
Dear Mr. Ryan:
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.
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Page 2 - Mr. Scott Ryan
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Zefon
INTERNATIONAL
Air Sampling Equipment
Medical Products
Injection Molding
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:
Zefon DuraCheck Blood Pressure Cuff
Indications For Use:
The Zefon blood pressure cuff is a reusable device to be used in conjunction with non-invasive automatic blood pressure monitors or non-invasive manual blood pressure measurement systems.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Division of Cardiovascular Devices | Concurrence of CDRH Qffice of Device Evaluation (ODE) | |
|---|---|---|
| 510(k) Number_K080366 | ||
| Prescription Use(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) |
| Page 5 Rev |
Image /page/2/Picture/9 description: The image shows a BSI Registered logo. The logo is circular with the letters "BSI" at the top. Inside the circle is an inverted triangle shape. Below the circle, the text "ISO 9001:2000 FM 98629" is printed.
5350 SW 1st Lane Ocala, Florida 34474, USA • Phone: 352-854-8080 • Fax: 352-854-7480 • www.zefon.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).