510(k) K922789
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 1993
- Date Received
- June 9, 1992
- 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