The following data is part of a premarket notification filed by The Surgical Company International Bv (as The 37company) with the FDA for Mistral-air Warming Unit.
| Device ID | K171234 |
| 510k Number | K171234 |
| Device Name: | Mistral-Air Warming Unit |
| Classification | System, Thermal Regulating |
| Applicant | The Surgical Company International BV (as The 37Company) Beeldschermweg 6F Amersfoort, NL 3821 Ah |
| Contact | Kees Van Hassel |
| 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 | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-04-27 |
| Decision Date | 2017-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| ET375250PM0 | K171234 | 000 |
| ET37MA1200PM0 | K171234 | 000 |
| 18719867001547 | K171234 | 000 |
| 18719867000069 | K171234 | 000 |