The following data is part of a premarket notification filed by Geratherm Medical Ag with the FDA for Geratherm Uniqueresc.
| Device ID | K093694 |
| 510k Number | K093694 |
| Device Name: | GERATHERM UNIQUERESC |
| 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 | 2009-11-30 |
| Decision Date | 2010-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00614801001502 | K093694 | 000 |
| 00614801000079 | K093694 | 000 |
| 00614801000086 | K093694 | 000 |
| 00614801000000 | K093694 | 000 |
| 00614801000017 | K093694 | 000 |
| 00614801000024 | K093694 | 000 |
| 00614801000031 | K093694 | 000 |
| 00614801000048 | K093694 | 000 |
| 00614801000055 | K093694 | 000 |
| 00614801001304 | K093694 | 000 |
| 00614801000062 | K093694 | 000 |