FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PORTA GAS COMPRESSED GAS CYLINDER CART
K Number: K910071
·
Decision Mar 22, 1991
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
22
Applicant Total
5
Review Days
72
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Basic Information
- Device Name
- PORTA GAS COMPRESSED GAS CYLINDER CART
- K Number
- K910071
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Sen Tech Medical Corp.
- Date Received
- January 9, 1991
- Decision Date
- March 22, 1991
- Product Code
- GET
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GET | Motor, Surgical Instrument, Pneumatic Powered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Sen Tech Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K855091 | CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS | Mar 14, 1986 | Substantially Equivalent |
| K854260 | CHEMPRO 1000 | Nov 19, 1985 | Substantially Equivalent |
| K851100 | CHEM PRO 1000 CHEMISTRY ANALYSIS | Jul 9, 1985 | Substantially Equivalent |
| K841575 | SENTECH'S ULAB 1000 CLINICAL CHEM. | Jul 6, 1984 | Substantially Equivalent |