FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CATALOG NO. I/A 100 AND KPE 200
K Number: K862334
·
Decision Jul 8, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
18
Review Days
28
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Basic Information
- Device Name
- CATALOG NO. I/A 100 AND KPE 200
- K Number
- K862334
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Ipax, Inc.
- Date Received
- June 10, 1986
- Decision Date
- July 8, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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