FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE
K Number: K837029
·
Decision Mar 22, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
20
Review Days
102
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Basic Information
- Device Name
- ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE
- K Number
- K837029
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- American Electromedics Corp.
- Date Received
- December 10, 1982
- Decision Date
- March 22, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
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