K031213 is an FDA 510(k) clearance for the AQUASENS FLUID MONITORING SYSTEM. This device is classified as a Insufflator, Hysteroscopic (Class II - Special Controls, product code HIG).
Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on April 30, 2003, 13 days after receiving the submission on April 17, 2003.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1700.
| 510(k) Number | K031213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2003 |
| Decision Date | April 30, 2003 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIG — Insufflator, Hysteroscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1700 |