510(k) K881141
K881141 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT". The FDA issued a decision of Substantially Equivalent on Apr 25, 1988. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 25, 1988
- Date Received
- Mar 17, 1988
- 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
- 510(k) Exempt