510(k) K904766

DEVILBISS MODEL 7352 SERIES by Devilbiss Health Care, Inc. — Product Code BZD

K904766 is an FDA 510(k) premarket notification submitted by Devilbiss Health Care, Inc. for the device "DEVILBISS MODEL 7352 SERIES". The FDA issued a decision of Substantially Equivalent on March 26, 1991. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), 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
March 26, 1991
Date Received
October 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type