FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AS/3 ESTPR MODULE
K Number: K953175
·
Decision Feb 6, 1997
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
13
Applicant Total
55
Review Days
580
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Basic Information
- Device Name
- AS/3 ESTPR MODULE
- K Number
- K953175
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Datex Division Instrumentarium Corp.
- Date Received
- July 7, 1995
- Decision Date
- February 6, 1997
- Product Code
- MLD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MLD | Monitor, St Segment With Alarm | FDA class 2 | Cardiovascular |
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Other Clearances by Datex Division Instrumentarium Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961247 | AS/3 LIGHT MONITOR | Oct 23, 1996 | Substantially Equivalent |
| K943458 | AS/3 AIRWAY MODULE | Feb 14, 1995 | Substantially Equivalent |
| K945234 | AS/3 MEMORY MODULE, M0MEM | Jan 27, 1995 | Substantially Equivalent |
| K933156 | DATEX AS/3 PATIENT MONITOR | Dec 30, 1994 | Substantially Equivalent |
| 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 |
| K933284 | AS/3 TM NETWORK | Jul 11, 1994 | Substantially Equivalent |