The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Rectal Temp. Telemetry Monitor.
| Device ID | K832404 |
| 510k Number | K832404 |
| Device Name: | RECTAL TEMP. TELEMETRY MONITOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-20 |
| Decision Date | 1983-09-12 |