K231961 is an FDA 510(k) clearance for the NIBPCuff. This device is classified as a Blood Pressure Cuff (Class II - Special Controls, product code DXQ).
Submitted by Shenzhen Sino-K Medical Technology Co.,Ltd (Shenzhen, CN). The FDA issued a Cleared decision on August 30, 2023, 58 days after receiving the submission on July 3, 2023.
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 | K231961 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2023 |
| Decision Date | August 30, 2023 |
| Days to Decision | 58 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. |