510(k) K873491
K873491 is an FDA 510(k) premarket notification submitted by B&B Medical Technologies, Inc. for the device "BLOCK, BITE, INTUBATION". The FDA issued a decision of Substantially Equivalent on October 20, 1987. The device falls under product code JAY (Support, Breathing Tube), a Class I device regulated under 21 CFR 868.5280. B&B Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1987
- Date Received
- August 31, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Support, Breathing Tube
- Device Class
- Class I
- Regulation Number
- 868.5280
- Review Panel
- AN
- Submission Type