510(k) K942645
K942645 is an FDA 510(k) premarket notification submitted by B & F Medical Products, Inc. for the device "B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG". The FDA issued a decision of Substantially Equivalent on July 27, 1994. The device falls under product code BXH (Gauge, Gas Pressure, Cylinder/Pipeline), a Class I device regulated under 21 CFR 868.2610. B & F Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1994
- Date Received
- June 3, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gauge, Gas Pressure, Cylinder/Pipeline
- Device Class
- Class I
- Regulation Number
- 868.2610
- Review Panel
- AN
- Submission Type