K981800 is an FDA 510(k) clearance for the SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606. This device is classified as a Hysteroscope (and Accessories) (Class II - Special Controls, product code HIH).
Submitted by Equal Diagnostics, Inc. (Exton, US). The FDA issued a Cleared decision on July 6, 1998, 46 days after receiving the submission on May 21, 1998.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K981800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 1998 |
| Decision Date | July 06, 1998 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | HIH — Hysteroscope (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1690 |