510(k) K904843
K904843 is an FDA 510(k) premarket notification submitted by Dalton Instrument Corp. for the device "OSCAR(TM) II CAPNOMETER & PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on April 9, 1991. The device falls under product code CBR (Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)), a Class II device regulated under 21 CFR 868.1700. Dalton Instrument Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 1991
- Date Received
- October 25, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- Device Class
- Class II
- Regulation Number
- 868.1700
- Review Panel
- AN
- Submission Type