K120125 is an FDA 510(k) clearance for the SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF. This device is classified as a Blood Pressure Cuff (Class II - Special Controls, product code DXQ).
Submitted by Ge Medical Systems Information Technologies, Inc. (Milwaukee, US). The FDA issued a Cleared decision on October 3, 2012, 260 days after receiving the submission on January 17, 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 | K120125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2012 |
| Decision Date | October 03, 2012 |
| Days to Decision | 260 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. |