The following data is part of a premarket notification filed by Innercool Therapies, Inc.- A Delaware Corporation with the FDA for Innercool Therapies, Inc., Rapidblue System.
| Device ID | K080908 |
| 510k Number | K080908 |
| Device Name: | INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM |
| Classification | System, Hypothermia, Intravenous, Cooling |
| Applicant | INNERCOOL THERAPIES, INC.- A DELAWARE CORPORATION 6740 TOP GUN STREET San Diego, CA 92121 |
| Contact | Jennifer Spinella |
| Correspondent | Jennifer Spinella INNERCOOL THERAPIES, INC.- A DELAWARE CORPORATION 6740 TOP GUN STREET San Diego, CA 92121 |
| Product Code | NCX |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-01 |
| Decision Date | 2008-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849111075411 | K080908 | 000 |
| 00849111075404 | K080908 | 000 |
| 00849111075398 | K080908 | 000 |
| 00849111075381 | K080908 | 000 |