FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COOL-AID
K Number: K931203
·
Decision Feb 22, 1994
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
92
Applicant Total
12
Review Days
350
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Basic Information
- Device Name
- COOL-AID
- K Number
- K931203
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5720
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Seabrook Medical Systems, Inc.
- Date Received
- March 9, 1993
- Decision Date
- February 22, 1994
- Product Code
- ILO
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ILO | Pack, Hot Or Cold, Water Circulating | FDA class 2 | Physical Medicine |
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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 |
| K952086 | TROPICAIR CONVECTIVE WARMING BLANKETS | Sep 6, 1995 | 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 |