K991525 is an FDA 510(k) clearance for the DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF. This device is classified as a Blood Pressure Cuff (Class II - Special Controls, product code DXQ).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on July 20, 1999, 78 days after receiving the submission on May 3, 1999.
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 | K991525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1999 |
| Decision Date | July 20, 1999 |
| Days to Decision | 78 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. |