510(k) K023420
K023420 is an FDA 510(k) premarket notification submitted by Medical Electronic Devices, Inc. for the device "PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB". The FDA issued a decision of Substantially Equivalent on October 25, 2002. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Medical Electronic Devices, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2002
- Date Received
- October 11, 2002
- Clearance Type
- Special
- 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