FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SELECTATEC SYSTEM
K Number: K760668
·
Decision Sep 27, 1976
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
56
Applicant Total
8
Review Days
10
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Basic Information
- Device Name
- SELECTATEC SYSTEM
- K Number
- K760668
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medishield, Inc.
- Date Received
- September 17, 1976
- Decision Date
- September 27, 1976
- Product Code
- CAD
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAD | Vaporizer, Anesthesia, Non-Heated | FDA class 2 | Anesthesiology |
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Other Clearances by Medishield, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K781103 | SPECTRASCAN | Sep 27, 1978 | Substantially Equivalent |
| K780645 | HMD-2000 BATTERY-POWERED MINI-DRILL, THE | May 3, 1978 | Substantially Equivalent |
| K780646 | AIR-PWOERED COLDRILL | Apr 28, 1978 | Substantially Equivalent |
| K780202 | MONOMER EVACUATION SYSTEM | Feb 21, 1978 | Substantially Equivalent |
| K770161 | MICROFENESTRATED HIP REPLACEMENT COMPON. | Jan 26, 1977 | Substantially Equivalent |
| K761020 | ANKLE (FREEMAN-SWANSON) | Nov 23, 1976 | Substantially Equivalent |
| K761021 | ANKLE INSTRUMENTS (FREEMAN-SWANSON) | Nov 23, 1976 | Substantially Equivalent |