FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOT/ICE DISPOSABLE BLANKET
K Number: K833564
·
Decision Nov 28, 1983
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
92
Applicant Total
4
Review Days
47
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Basic Information
- Device Name
- HOT/ICE DISPOSABLE BLANKET
- K Number
- K833564
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5720
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Thermo Temp, Inc.
- Date Received
- October 12, 1983
- Decision Date
- November 28, 1983
- 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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