Seabrook Medical Systems, Inc.
Walker, MI, US
Seabrook Medical Systems, Inc. appears in FDA device records in Walker, MI. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Seabrook Medical Systems, Inc. between 1984 and 1995. The busiest year on record is 1990, with 3. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1987 | 1 |
| 1988 | 2 |
| 1990 | 3 |
| 1991 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K952086 | TROPICAIR CONVECTIVE WARMING BLANKETS | DWJ | Substantially Equivalent | |
| K946196 | TROPICAIR CONVECTIVE WARING SYSTEM | DWJ | Substantially Equivalent | |
| K931203 | COOL-AID | ILO | Substantially Equivalent | |
| K923104 | TROPIC-AIR | DWJ | Substantially Equivalent | |
| K914182 | GOLDEN THERMAL(R) | ILO | Substantially Equivalent | |
| K902756 | TROPI-COOL | DWJ | Substantially Equivalent | |
| K902269 | ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY | ILO | Substantially Equivalent | |
| K902268 | PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM. | ILO | Substantially Equivalent | |
| K882310 | DUAL-TEMP(TM) COOLING/WARMING UNIT | ILO | Substantially Equivalent | |
| K881322 | MINI-TEMP(TM) | DWJ | Substantially Equivalent | |
| K873699 | ECMO-TEMP (TM) BLOOD WARMING DEVICE | DWC | Substantially Equivalent | |
| K843146 | MICRO-TEMP PUMPS & MICRO-TEMP PADS | ILO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain