FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AQUAMATIC K-MODULE MODEL K-10
K Number: K761337
·
Decision Jan 10, 1977
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
3
Applicant Total
6
Review Days
14
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Basic Information
- Device Name
- AQUAMATIC K-MODULE MODEL K-10
- K Number
- K761337
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Gorman Rupp Industries
- Date Received
- December 27, 1976
- Decision Date
- January 10, 1977
- Product Code
- JRR
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| JRR | Regulator, Temperature | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JRR), ordered by most recent decision date.
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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 |
| K760910 | DISPOSABLE K-PADS | Dec 16, 1976 | Substantially Equivalent |
| K761087 | ELECTRONIC CONTROL UNIT | Dec 6, 1976 | Substantially Equivalent |