K910982 is an FDA 510(k) clearance for the INNERVISION IRRIGATION PUMP. This device is classified as a Monitor, Heart-valve Movement, Fetal, Ultrasonic (Class II - Special Controls, product code HEI).
Submitted by M.D. Engineering, Inc. (Hayward, US). The FDA issued a Cleared decision on August 26, 1991, 172 days after receiving the submission on March 7, 1991.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2660.
| 510(k) Number | K910982 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1991 |
| Decision Date | August 26, 1991 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HEI — Monitor, Heart-valve Movement, Fetal, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2660 |