FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RECOVER ADULT VEIN WARMER
K Number: K963689
·
Decision Dec 12, 1996
Classifications
1
FEI Numbers
377
Registration Numbers
377
Same Product Code
81
Applicant Total
2
Review Days
87
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Basic Information
- Device Name
- RECOVER ADULT VEIN WARMER
- K Number
- K963689
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5710
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Florida Medical Industries, Inc.
- Date Received
- September 16, 1996
- Decision Date
- December 12, 1996
- Product Code
- IMD
- 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 |
|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | FDA class 1 | Physical Medicine |
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Other Clearances by Florida Medical Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964523 | RECOVER INFANT HEEL WARMER (5100) | Feb 10, 1997 | Substantially Equivalent |