The following data is part of a premarket notification filed by Seabrook Medical Systems, Inc. with the FDA for Ecmo-temp (tm) Blood Warming Device.
| Device ID | K873699 |
| 510k Number | K873699 |
| Device Name: | ECMO-TEMP (TM) BLOOD WARMING DEVICE |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| 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 | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-16 |
| Decision Date | 1987-12-22 |