FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TROPICAIR CONVECTIVE WARMING BLANKETS
K Number: K952086
·
Decision Sep 6, 1995
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
12
Review Days
126
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Basic Information
- Device Name
- TROPICAIR CONVECTIVE WARMING BLANKETS
- K Number
- K952086
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Seabrook Medical Systems, Inc.
- Date Received
- May 3, 1995
- Decision Date
- September 6, 1995
- Product Code
- DWJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWJ | System, Thermal Regulating | FDA class 2 | Cardiovascular |
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Other Clearances by Seabrook Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K946196 | TROPICAIR CONVECTIVE WARING SYSTEM | Sep 6, 1995 | Substantially Equivalent |
| K931203 | COOL-AID | Feb 22, 1994 | Substantially Equivalent |
| K923104 | TROPIC-AIR | Jul 13, 1993 | Substantially Equivalent |
| K914182 | GOLDEN THERMAL(R) | Oct 18, 1991 | Substantially Equivalent |
| K902756 | TROPI-COOL | Oct 22, 1990 | Substantially Equivalent |
| K902269 | ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY | Jun 21, 1990 | Substantially Equivalent |
| K902268 | PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM. | Jun 21, 1990 | Substantially Equivalent |
| K882310 | DUAL-TEMP(TM) COOLING/WARMING UNIT | Sep 23, 1988 | Substantially Equivalent |
| K881322 | MINI-TEMP(TM) | Jun 22, 1988 | Substantially Equivalent |
| K873699 | ECMO-TEMP (TM) BLOOD WARMING DEVICE | Dec 22, 1987 | Substantially Equivalent |