FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
OSCAR(TM) II CAPNOMETER & PULSE OXIMETER
K Number: K904843
·
Decision Apr 9, 1991
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
4
Applicant Total
5
Review Days
166
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Basic Information
- Device Name
- OSCAR(TM) II CAPNOMETER & PULSE OXIMETER
- K Number
- K904843
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Dalton Instrument Corp.
- Date Received
- October 25, 1990
- Decision Date
- April 9, 1991
- Product Code
- CBR
- 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 |
|---|---|---|---|
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | FDA class 2 | Anesthesiology |
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