FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ABM ANESTHESIA & BRAIN MONITOR
K Number: K840232
·
Decision Apr 6, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
55
Review Days
87
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Basic Information
- Device Name
- ABM ANESTHESIA & BRAIN MONITOR
- K Number
- K840232
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Datex Division Instrumentarium Corp.
- Date Received
- January 10, 1984
- Decision Date
- April 6, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
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| K933285 | DATEX AS/3 TM ANAESTHESIA MONITOR | Nov 14, 1994 | Substantially Equivalent |
| K943456 | AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT | Oct 17, 1994 | Substantially Equivalent |
| K923172 | ANAESTHESIA RECORD KEEPER | Aug 9, 1994 | Substantially Equivalent |
| K935477 | AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD | Aug 1, 1994 | Substantially Equivalent |
| K943457 | AS/3 PRESSURE TEMPERATURE MODULE, M-PT | Jul 27, 1994 | Substantially Equivalent |