FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ACU-HALT
K Number: K945374
·
Decision Aug 9, 1995
Classifications
0
FEI Numbers
10
Registration Numbers
10
Same Product Code
80
Applicant Total
1
Review Days
280
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Basic Information
- Device Name
- ACU-HALT
- K Number
- K945374
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Eva-Health USA, Inc.
- Date Received
- November 2, 1994
- Decision Date
- August 9, 1995
- Product Code
- LDQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
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