The following data is part of a premarket notification filed by Geratherm Ag with the FDA for Geratherm Babywatch Temperature Monitor.
| Device ID | K001281 |
| 510k Number | K001281 |
| Device Name: | GERATHERM BABYWATCH TEMPERATURE MONITOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | GERATHERM AG 2000 TOWN CENTER SUITE 1900 Southfield, MI 48075 -2645 |
| Contact | Ed Holter |
| Correspondent | Ed Holter GERATHERM AG 2000 TOWN CENTER SUITE 1900 Southfield, MI 48075 -2645 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-21 |
| Decision Date | 2001-06-12 |