The following data is part of a premarket notification filed by Equal Diagnostics, Inc. with the FDA for Sentinel Cholinesterase Liquid Model Number 17.019a & 17.606.
| Device ID | K981800 |
| 510k Number | K981800 |
| Device Name: | SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606 |
| Classification | Hysteroscope (and Accessories) |
| Applicant | EQUAL DIAGNOSTICS, INC. 115 SUMMIT DR. Exton, PA 19341 |
| Contact | Brenda Y Kan |
| Correspondent | Brenda Y Kan EQUAL DIAGNOSTICS, INC. 115 SUMMIT DR. Exton, PA 19341 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-21 |
| Decision Date | 1998-07-06 |