The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Temperature Monitor.
| Device ID | K772217 |
| 510k Number | K772217 |
| Device Name: | TEMPERATURE MONITOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | HUDSON OXYGEN THERAPY SALES CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-02 |
| Decision Date | 1977-12-13 |