510(k) K881849
K881849 is an FDA 510(k) premarket notification submitted by B&B Medical Technologies, Inc. for the device "BODAI M.D.D. ADAPTOR(TM)". The FDA issued a decision of Substantially Equivalent on July 1, 1988. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. B&B Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 1988
- Date Received
- May 2, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Connector, Airway (Extension)
- Device Class
- Class I
- Regulation Number
- 868.5810
- Review Panel
- AN
- Submission Type