The following data is part of a premarket notification filed by Seabrook Medical Systems, Inc. with the FDA for Tropicair Convective Waring System.
| Device ID | K946196 |
| 510k Number | K946196 |
| Device Name: | TROPICAIR CONVECTIVE WARING SYSTEM |
| Classification | System, Thermal Regulating |
| Applicant | SEABROOK MEDICAL SYSTEMS, INC. 4043 MCMANN RD. Cincinnati, OH 45245 -1903 |
| Contact | Laura M Cannon |
| Correspondent | Laura M Cannon SEABROOK MEDICAL SYSTEMS, INC. 4043 MCMANN RD. Cincinnati, OH 45245 -1903 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-20 |
| Decision Date | 1995-09-06 |