The following data is part of a premarket notification filed by Automated Ophthalmics, Inc. with the FDA for Automated Ophthalmics Softips.
| Device ID | K992998 |
| 510k Number | K992998 |
| Device Name: | AUTOMATED OPHTHALMICS SOFTIPS |
| Classification | Tonometer, Manual |
| Applicant | AUTOMATED OPHTHALMICS, INC. 8253 GLEMAR RD. Ellicott, MD 21043 |
| Contact | Norman Bickman |
| Correspondent | Norman Bickman AUTOMATED OPHTHALMICS, INC. 8253 GLEMAR RD. Ellicott, MD 21043 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-07 |
| Decision Date | 2000-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000603805 | K992998 | 000 |