The following data is part of a premarket notification filed by Rowan Products, Inc. with the FDA for Algesiometer.
| Device ID | K801907 |
| 510k Number | K801907 |
| Device Name: | ALGESIOMETER |
| Classification | Esthesiometer |
| Applicant | ROWAN PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GXB |
| CFR Regulation Number | 882.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-11 |
| Decision Date | 1980-09-16 |