DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES

K080366 · Zefon Intl. · DXQ · Jun 9, 2008 · Cardiovascular

Device Facts

• Record ID: K080366
• Device Name: DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES
• Applicant: Zefon Intl.
• Product Code: DXQ · Cardiovascular
• Decision Date: Jun 9, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Zefon DuraCheck Blood Pressure Cuffs are reusable accessories for non-invasive blood pressure (NIBP) monitoring. Available in multiple sizes (Child, Small Adult, Adult, Large Adult, Thigh). Device functions as a pneumatic interface between patient limb and NIBP monitor/sphygmomanometer; cuff inflates to occlude artery and deflates to allow measurement of blood pressure via oscillometric or auscultatory methods. Used in clinical settings by healthcare professionals. Benefits include reliable, non-invasive blood pressure assessment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Reusable pneumatic blood pressure cuff. Available in various sizes. Compatible with standard non-invasive automatic or manual blood pressure measurement systems. ISO 9001:2000 certified manufacturing.

Indications for Use

Indicated for use with non-invasive automatic or manual blood pressure monitors for patients requiring blood pressure measurement.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and strength. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

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 [phone]. 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 [phone] or [phone] 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<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(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: [phone] • Fax: [phone] • www.zefon.com