FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEMPTEK T-1000 THERAPEUTIC COOLING UNIT
K Number: K891091
·
Decision Mar 26, 1990
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
92
Applicant Total
3
Review Days
389
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Basic Information
- Device Name
- TEMPTEK T-1000 THERAPEUTIC COOLING UNIT
- K Number
- K891091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5720
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Temptek, Inc.
- Date Received
- March 2, 1989
- Decision Date
- March 26, 1990
- 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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