510(k) K832999
K832999 is an FDA 510(k) premarket notification submitted by Litton Medical Electronics for the device "RESPIRATION MONITOR". The FDA issued a decision of Substantially Equivalent on Feb 13, 1984. The device falls under product code FLS (Monitor, Apnea, Facility Use), a Class II device regulated under 21 CFR 868.2377. Litton Medical Electronics has 37 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 13, 1984
- Date Received
- Aug 18, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Apnea, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.2377
- Review Panel
- AN
- Submission Type
- 510(k)