The following data is part of a premarket notification filed by Seabrook Medical Systems, Inc. with the FDA for Tropic-air.
| Device ID | K923104 |
| 510k Number | K923104 |
| Device Name: | TROPIC-AIR |
| Classification | System, Thermal Regulating |
| Applicant | SEABROOK MEDICAL SYSTEMS, INC. 673 WILMER AVE. Cincinnati, OH 45226 -1859 |
| Contact | Mark J Buch |
| Correspondent | Mark J Buch SEABROOK MEDICAL SYSTEMS, INC. 673 WILMER AVE. Cincinnati, OH 45226 -1859 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-25 |
| Decision Date | 1993-07-13 |