510(k) K833982

MODEL IV 100B-DA INFANT VENTILATOR by Sechrist Industries, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1984
Date Received
November 17, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type