510(k) K913753
K913753 is an FDA 510(k) premarket notification submitted by B&B Medical Technologies, Inc. for the device "BODAI NEO2 -SAFE AIRWAY PRESSURE CAP". The FDA issued a decision of Substantially Equivalent on October 23, 1991. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. B&B Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1991
- Date Received
- August 21, 1991
- 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