The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Tecnol Telemetry Unit Pouch.
| Device ID | K802849 |
| 510k Number | K802849 |
| Device Name: | TECNOL TELEMETRY UNIT POUCH |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 368 FAIRVIEW AVE. Hammonton, NJ 08037 -0268 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-12 |
| Decision Date | 1980-12-16 |