510(k) K771134
K771134 is an FDA 510(k) premarket notification submitted by Air Products & Chemicals, Inc. for the device "ANESTHESIA BREATHING CIRCUIT". The FDA issued a decision of Substantially Equivalent on Jul 5, 1977. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Air Products & Chemicals, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 5, 1977
- Date Received
- Jun 23, 1977
- 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