FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ASTRA 2,3,4 AND 6: CHIP REVISION
K Number: K863000
·
Decision Aug 19, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
76
Review Days
11
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Basic Information
- Device Name
- ASTRA 2,3,4 AND 6: CHIP REVISION
- K Number
- K863000
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Cardiac Pacemakers, Inc.
- Date Received
- August 8, 1986
- Decision Date
- August 19, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
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