FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS
K Number: K905207
·
Decision Jan 22, 1991
Classifications
1
FEI Numbers
467
Registration Numbers
468
Same Product Code
26
Applicant Total
15
Review Days
63
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Basic Information
- Device Name
- MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS
- K Number
- K905207
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5700
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Micro Surgical Instruments Corp.
- Date Received
- November 20, 1990
- Decision Date
- January 22, 1991
- 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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