510(k) K863510
K863510 is an FDA 510(k) premarket notification submitted by B&B Medical Technologies, Inc. for the device "OXY-OFF(TM)". The FDA issued a decision of Substantially Equivalent on October 22, 1986. The device falls under product code BXY (Flowmeter, Calibration, Gas), a Class I device regulated under 21 CFR 868.2350. B&B Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 1986
- Date Received
- September 9, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flowmeter, Calibration, Gas
- Device Class
- Class I
- Regulation Number
- 868.2350
- Review Panel
- AN
- Submission Type