510(k) K961126

PULSE DOSE SERIES by Devilbiss Health Care, Inc. — Product Code NFB

K961126 is an FDA 510(k) premarket notification submitted by Devilbiss Health Care, Inc. for the device "PULSE DOSE SERIES". The FDA issued a decision of Substantially Equivalent on October 21, 1996. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Devilbiss Health Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1996
Date Received
March 21, 1996
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