The following data is part of a premarket notification filed by The Surgical Company International Bv with the FDA for Mistral-air Warming System.
| Device ID | K101705 |
| 510k Number | K101705 |
| Device Name: | MISTRAL-AIR WARMING SYSTEM |
| Classification | System, Thermal Regulating |
| Applicant | THE SURGICAL COMPANY INTERNATIONAL BV 3821 AH AMERSFOORT Beeldschermweg 6g, NL |
| Contact | Adriaan P Intveld |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-17 |
| Decision Date | 2010-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18719867000038 | K101705 | 000 |
| 18719867001134 | K101705 | 000 |
| 18719867001172 | K101705 | 000 |
| 18719867001219 | K101705 | 000 |
| 18719867001240 | K101705 | 000 |
| 18719867001295 | K101705 | 000 |
| 18719867001332 | K101705 | 000 |
| 18719867001370 | K101705 | 000 |
| 18719867001400 | K101705 | 000 |
| 18719867001455 | K101705 | 000 |
| ET37MA02010PM0 | K101705 | 000 |
| ET37MA0320PM0 | K101705 | 000 |
| ET37MA0330PM0 | K101705 | 000 |
| ET37MA0340PM0 | K101705 | 000 |
| ET37MA0350PM0 | K101705 | 000 |
| ET37MA0360PM0 | K101705 | 000 |
| 18719867001097 | K101705 | 000 |
| 18719867001059 | K101705 | 000 |
| 18719867001011 | K101705 | 000 |
| 18719867000236 | K101705 | 000 |
| 18719867000434 | K101705 | 000 |
| 18719867000472 | K101705 | 000 |
| 18719867000533 | K101705 | 000 |
| 18719867000571 | K101705 | 000 |
| 18719867000618 | K101705 | 000 |
| 18719867000656 | K101705 | 000 |
| 18719867000694 | K101705 | 000 |
| 18719867000731 | K101705 | 000 |
| 18719867000779 | K101705 | 000 |
| 18719867000816 | K101705 | 000 |
| 18719867002087 | K101705 | 000 |
| 18719867002094 | K101705 | 000 |
| 18719867000939 | K101705 | 000 |
| 18719867002100 | K101705 | 000 |
| ET37MA0365PM0 | K101705 | 000 |
| ET37MA0400PM0 | K101705 | 000 |
| ET37MA2280PM0 | K101705 | 000 |
| ET37MA2285PM0 | K101705 | 000 |
| ET37MA2286PM0 | K101705 | 000 |
| ET37MA2290PM0 | K101705 | 000 |
| ET37MA2400PM0 | K101705 | 000 |
| ET37MA2450PM0 | K101705 | 000 |
| ET37MA2475PM0 | K101705 | 000 |
| ET37MA3320PM1 | K101705 | 000 |
| ET37MA3330PM1 | K101705 | 000 |
| ET37MA3340PM1 | K101705 | 000 |
| ET37MA3350PM1 | K101705 | 000 |
| ET37MA3360PM1 | K101705 | 000 |
| ET37MA3365PM1 | K101705 | 000 |
| ET37MA3400PM0 | K101705 | 000 |
| ET37MA3450PM0 | K101705 | 000 |
| ET37MA2270PM0 | K101705 | 000 |
| ET37MA2265PM0 | K101705 | 000 |
| ET37MA2260PM0 | K101705 | 000 |
| ET37MA0450PM0 | K101705 | 000 |
| ET37MA0510PM0 | K101705 | 000 |
| ET37MA1100PM0 | K101705 | 000 |
| ET37MA1610PM0 | K101705 | 000 |
| ET37MA1620PM0 | K101705 | 000 |
| ET37MA1630PM0 | K101705 | 000 |
| ET37MA1640PM0 | K101705 | 000 |
| ET37MA1710PM0 | K101705 | 000 |
| ET37MA1720PM0 | K101705 | 000 |
| ET37MA1730PM0 | K101705 | 000 |
| ET37MA1740PM0 | K101705 | 000 |
| ET37MA2220PM0 | K101705 | 000 |
| ET37MA2230PM0 | K101705 | 000 |
| ET37MA2240PM0 | K101705 | 000 |
| ET37MA2250PM0 | K101705 | 000 |
| ET37MA3475PM0 | K101705 | 000 |