FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VICKERS MEDICAL MODEL 112 TREONIC DC2
K Number: K791645
·
Decision Oct 2, 1979
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
22
Review Days
40
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Basic Information
- Device Name
- VICKERS MEDICAL MODEL 112 TREONIC DC2
- K Number
- K791645
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Vickers America Medical Corp.
- Date Received
- August 23, 1979
- Decision Date
- October 2, 1979
- Product Code
- FKW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FKW | Tip, Vessel | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKW), ordered by most recent decision date.
T SERIES VESSEL TIPS
FDA 510(k)
FDA Class 2
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VESSEL TIPS, SIZES 13-18
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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| K810792 | NEOCARE TEMPERATURE MONITOR | Apr 29, 1981 | Substantially Equivalent |
| K810067 | 140 NEOCARE AIR CONTROLLED INCUBATOR | Mar 11, 1981 | Substantially Equivalent |
| K810571 | NEOCARE OXYGEN MONITOR | Mar 11, 1981 | Substantially Equivalent |