FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE
K Number: K934677
·
Decision Jul 5, 1994
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
8
Review Days
280
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Basic Information
- Device Name
- U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE
- K Number
- K934677
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- U.S. Medical Corp.
- Date Received
- September 28, 1993
- Decision Date
- July 5, 1994
- Product Code
- FMT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | FDA class 2 | General Hospital |
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Other Clearances by U.S. Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K924440 | U.S. MEDICAL PS-7000 DIALYSIS SCALE | May 26, 1993 | Substantially Equivalent |
| K924441 | U.S. MEDICAL PS-6000 WHEELCHAIR SCALE | Feb 12, 1993 | Substantially Equivalent |
| K910583 | U.S. MEDICAL PS-3000 NEONATAL SCALE | Mar 21, 1991 | Substantially Equivalent |
| K910581 | U.S. MEDICAL PS-1000 PEDIATRIC SCALE | Mar 21, 1991 | Substantially Equivalent |
| K910582 | U.S. MEDICAL PS-2000 PEDIATRIC SCALE | Mar 21, 1991 | Substantially Equivalent |
| K896633 | AUTO-CUFF(TM) | Feb 1, 1990 | Substantially Equivalent |
| K801053 | PULSED GALVANIC STIMULATOR, 450-DYNAMAX | Jun 4, 1980 | Substantially Equivalent |