The following data is part of a premarket notification filed by Emcools Emergency Medical Cooling Systems Ag with the FDA for Emcoolspad.
| Device ID | K100071 |
| 510k Number | K100071 |
| Device Name: | EMCOOLSPAD |
| Classification | Hyperthermia Monitor |
| Applicant | EMCOOLS EMERGENCY MEDICAL COOLING SYSTEMS AG BRUCKNERSTRASSE 6/7A 1040 WIEN Vienna, AT 1040 |
| Contact | Michael Kuehling |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | NZE |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-01-11 |
| Decision Date | 2010-10-12 |
| Summary: | summary |