510(k) K760149
K760149 is an FDA 510(k) premarket notification submitted by Omnicon Medical Corp. for the device "CONDUCTIVE ANESTHSIA BREATH. CIRCUIT". The FDA issued a decision of Substantially Equivalent on July 19, 1976. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Omnicon Medical Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1976
- Date Received
- June 30, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Circuit, Breathing (W Connector, Adaptor, Y Piece)
- Device Class
- Class I
- Regulation Number
- 868.5240
- Review Panel
- AN
- Submission Type