K012455 is an FDA 510(k) clearance for the WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM. This device is classified as a Blood Pressure Cuff (Class II - Special Controls, product code DXQ).
Submitted by Welch Allyn, Inc. (Arden, US). The FDA issued a Cleared decision on August 17, 2001, 16 days after receiving the submission on August 1, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1120. 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 | K012455 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2001 |
| Decision Date | August 17, 2001 |
| Days to Decision | 16 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXQ — Blood Pressure Cuff |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1120 |
| Definition | 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. |