The following data is part of a premarket notification filed by Seabrook Medical Systems, Inc. with the FDA for Micro-temp Pumps & Micro-temp Pads.
| Device ID | K843146 |
| 510k Number | K843146 |
| Device Name: | MICRO-TEMP PUMPS & MICRO-TEMP PADS |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | SEABROOK MEDICAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-10 |
| Decision Date | 1984-08-17 |