FDA 510(k)
Substantially Equivalent
🇺🇸 United States
OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY
K Number: K837443
·
Decision Jun 10, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
1
Review Days
42
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Basic Information
- Device Name
- OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY
- K Number
- K837443
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Medical Diagnostic Instruments, Inc.
- Date Received
- April 29, 1983
- Decision Date
- June 10, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N