CELSIUS CONTROL SYSTEM
System, Hypothermia, Intravenous, Cooling
INNERCOOL THERAPIES, INC.
The following data is part of a premarket notification filed by Innercool Therapies, Inc. with the FDA for Celsius Control System.
Pre-market Notification Details
| Device ID | K033623 |
| 510k Number | K033623 |
| Device Name: | CELSIUS CONTROL SYSTEM |
| Classification | System, Hypothermia, Intravenous, Cooling |
| Applicant | INNERCOOL THERAPIES, INC. 3931 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Steve Reitzler |
| Correspondent | Steve Reitzler INNERCOOL THERAPIES, INC. 3931 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | NCX |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-18 |
| Decision Date | 2004-05-21 |
| Summary: | summary |
Trademark Results [CELSIUS CONTROL SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELSIUS CONTROL SYSTEM 78149414 not registered Dead/Abandoned |
INNERCOOL THERAPIES, INC. 2002-07-31 |
 CELSIUS CONTROL SYSTEM 76440147 not registered Dead/Abandoned |
INNERCOOL THERAPIES, INC. 2002-08-02 |
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