FDA 510(k)
Substantially Equivalent
🇨🇦 Canada
SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2
K Number: K854533
·
Decision Sep 30, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
17
Review Days
321
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Basic Information
- Device Name
- SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2
- K Number
- K854533
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Madsen Electronics (Canada) , Ltd.
- Date Received
- November 13, 1985
- Decision Date
- September 30, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- NE
- Third Party
- N
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