The following data is part of a premarket notification filed by Stihler Electronic Gmbh with the FDA for Astopad Patient Warming System.
| Device ID | K202197 |
| 510k Number | K202197 |
| Device Name: | Astopad Patient Warming System |
| Classification | System, Thermal Regulating |
| Applicant | Stihler Electronic GmbH Julius-Hoelder-Strasse 36 Stuttgart, DE 70597 |
| Contact | Jens- Peter Weege |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-08-05 |
| Decision Date | 2020-09-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260114140030 | K202197 | 000 |
| 04260114140269 | K202197 | 000 |
| 04260114140252 | K202197 | 000 |
| 04260114140245 | K202197 | 000 |
| 04260114140238 | K202197 | 000 |
| 04260114140221 | K202197 | 000 |