510(k) K961742

DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM by Alm Surgical Equipment, Inc. — Product Code FQO

K961742 is an FDA 510(k) premarket notification submitted by Alm Surgical Equipment, Inc. for the device "DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM". The FDA issued a decision of Substantially Equivalent on July 26, 1996. The device falls under product code FQO (Table, Operating-Room, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Alm Surgical Equipment, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1996
Date Received
May 6, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Ac-Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type