510(k) K923660
K923660 is an FDA 510(k) premarket notification submitted by Medisonic U.S.A., Inc. for the device "MEDISONIC OXYGEN FLOW CONTROLLER". The FDA issued a decision of Substantially Equivalent on January 27, 1993. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Medisonic U.S.A., Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 1993
- Date Received
- July 22, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Conserver, Oxygen
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type