The following data is part of a premarket notification filed by Geratherm Medical Ag with the FDA for Unique Temp Warming Blankets, Model 8001140xxx.
| Device ID | K093244 |
| 510k Number | K093244 |
| Device Name: | UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX |
| Classification | System, Thermal Regulating |
| Applicant | GERATHERM MEDICAL AG SCHWARZWALDSTRASSE 5 Tuttligen, DE 78532 |
| Contact | Andrea Pecsi |
| Correspondent | Andrea Pecsi GERATHERM MEDICAL AG SCHWARZWALDSTRASSE 5 Tuttligen, DE 78532 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-15 |
| Decision Date | 2010-10-19 |
| Summary: | summary |