FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DELTATRAC(TM) METABOLIC MONITOR
K Number: K864603
·
Decision Mar 17, 1987
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
32
Applicant Total
55
Review Days
113
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Basic Information
- Device Name
- DELTATRAC(TM) METABOLIC MONITOR
- K Number
- K864603
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Datex Division Instrumentarium Corp.
- Date Received
- November 24, 1986
- Decision Date
- March 17, 1987
- Product Code
- BZL
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BZL | Computer, Oxygen-Uptake | FDA class 2 | Anesthesiology |
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Other Clearances by Datex Division Instrumentarium Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K953175 | AS/3 ESTPR MODULE | Feb 6, 1997 | Substantially Equivalent |
| 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 |