K071885 is an FDA 510(k) clearance for the ANTIMICROBIAL AND SINGLE-PATIENT CUFFS. This device is classified as a Antimicrobial Blood Pressure Cuff (Class II - Special Controls, product code OED).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on December 20, 2007, 164 days after receiving the submission on July 9, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1120. Device Is A Replacement Cuff To Be Used In Conjunction With A Non-invasive Blood Pressure Monitor. Together The Devices Determine Blood Pressures And Heart Rate. This Particular Cuff Contains An Embedded Antimicrobial. A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve(cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure..
| 510(k) Number | K071885 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2007 |
| Decision Date | December 20, 2007 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | OED — Antimicrobial Blood Pressure Cuff |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1120 |
| Definition | Device Is A Replacement Cuff To Be Used In Conjunction With A Non-invasive Blood Pressure Monitor. Together The Devices Determine Blood Pressures And Heart Rate. This Particular Cuff Contains An Embedded Antimicrobial. A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve(cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure. |