FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE K-PADS
K Number: K760910
·
Decision Dec 16, 1976
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
92
Applicant Total
6
Review Days
50
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Basic Information
- Device Name
- DISPOSABLE K-PADS
- K Number
- K760910
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5720
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Gorman Rupp Industries
- Date Received
- October 27, 1976
- Decision Date
- December 16, 1976
- 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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Other Clearances by Gorman Rupp Industries
| K Number | Device Name | ||
|---|---|---|---|
| K771537 | AQUAMATIC K-MODULE MODEL K-20 | Sep 6, 1977 | Substantially Equivalent |
| K770839 | AQUAMATIC K-77 | Jun 8, 1977 | Substantially Equivalent |
| K770232 | BLOOD/FLUID WARMER MODEL DW-1000A | Feb 14, 1977 | Substantially Equivalent |
| K761337 | AQUAMATIC K-MODULE MODEL K-10 | Jan 10, 1977 | Substantially Equivalent |
| K761087 | ELECTRONIC CONTROL UNIT | Dec 6, 1976 | Substantially Equivalent |