The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Aesthesiometer.
| Device ID | K874300 |
| 510k Number | K874300 |
| Device Name: | AESTHESIOMETER |
| Classification | Discriminator, Two-point |
| Applicant | ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
| Contact | Roberty R Moore |
| Correspondent | Roberty R Moore ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
| Product Code | GWI |
| CFR Regulation Number | 882.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-20 |
| Decision Date | 1987-11-06 |