510(k) K854573
K854573 is an FDA 510(k) premarket notification submitted by Artec Environmental Monitoring Division for the device "ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE". The FDA issued a decision of Substantially Equivalent on January 3, 1986. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Artec Environmental Monitoring Division has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 1986
- Date Received
- November 14, 1985
- 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