FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NICE PACK
K Number: K832193
·
Decision Aug 31, 1983
Classifications
1
FEI Numbers
471
Registration Numbers
472
Same Product Code
26
Applicant Total
21
Review Days
54
Basic Information
- Device Name
- NICE PACK
- K Number
- K832193
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5700
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- UNIVERSAL MEDICAL INSTRUMENT CORP.
- Date Received
- July 8, 1983
- Decision Date
- August 31, 1983
- Product Code
- IME
- 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 |
|---|---|---|---|
| IME | Pack, Hot Or Cold, Reusable | FDA class 1 | Physical Medicine |
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