FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ARM SHIELD FOR ANESTHESIA
K Number: K792147
·
Decision Dec 6, 1979
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
12
Applicant Total
24
Review Days
45
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Basic Information
- Device Name
- ARM SHIELD FOR ANESTHESIA
- K Number
- K792147
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.3910
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medical Innovations Corp.
- Date Received
- October 22, 1979
- Decision Date
- December 6, 1979
- Product Code
- BTX
- 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 |
|---|---|---|---|
| BTX | Board, Arm (With Cover), Sterile | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTX), ordered by most recent decision date.
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UNIVERSALLY ADJUSTABLE ARMBOARD
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ALLEN LATERAL ARMBOARD
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BOARD, ARM (WITH COVER)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Medical Innovations Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K945612 | MIC NASOGASTRIC-GASTROJEJUNAL FEEDING TUBE | Apr 19, 1995 | Substantially Equivalent |
| K940548 | MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBE | Feb 22, 1995 | Substantially Equivalent |
| K943685 | MIC DISPOSABLE SNARE | Nov 1, 1994 | Substantially Equivalent |
| K926581 | MIC TRANSGASTRIC JEJUNAL TUBE | Sep 28, 1994 | Substantially Equivalent |
| K921652 | MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT | May 2, 1994 | Unknown |
| K921370 | MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION | May 2, 1994 | Unknown |
| K924065 | MIC PEG TUBE | Feb 17, 1994 | Unknown |
| K922667 | MIC LOW PROFILE GASTROSTOMY TUBE | Dec 1, 1993 | Unknown |
| K913320 | MIL CM-II COAGULATION MACHINE | Jun 16, 1992 | Substantially Equivalent |
| K903531 | ANTICARDIOLIPIN ANTIBODY TEST SYSTEM | Jan 25, 1991 | Substantially Equivalent |