510(k) K023420

PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB by Medical Electronic Devices, Inc. — Product Code NFB

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