The following data is part of a premarket notification filed by Computed Anatomy, Inc. with the FDA for Topographic Modeling System 2 Tms-2.
| Device ID | K944207 |
| 510k Number | K944207 |
| Device Name: | TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 |
| Classification | Keratoscope, Ac-powered |
| Applicant | COMPUTED ANATOMY, INC. 28 W. 36TH ST. New York, NY 10018 |
| Contact | Charles J Klein |
| Correspondent | Charles J Klein COMPUTED ANATOMY, INC. 28 W. 36TH ST. New York, NY 10018 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-29 |
| Decision Date | 1994-12-07 |