K122058 is an FDA 510(k) clearance for the FLEXIPORT ECOCUFF. This device is classified as a Blood Pressure Cuff (Class II — Special Controls, product code DXQ).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on November 5, 2012, 115 days after receiving the submission on July 13, 2012.
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 | K122058 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2012 |
| Decision Date | November 05, 2012 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| 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. |