FDA 510(k)
Substantially Equivalent
🇺🇸 United States
PERSONAL ALARM SYSTEM (PAS)
K Number: K944961
·
Decision Aug 7, 1995
Classifications
0
FEI Numbers
8
Registration Numbers
8
Same Product Code
80
Applicant Total
1
Review Days
304
Basic Information
- Device Name
- PERSONAL ALARM SYSTEM (PAS)
- K Number
- K944961
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CYTOPROBE CORP.
- Date Received
- October 7, 1994
- Decision Date
- August 7, 1995
- Product Code
- LDQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
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