510(k) K990098

VENTLAB VERIFY II by Ventlab Corp. — Product Code BTR

K990098 is an FDA 510(k) premarket notification submitted by Ventlab Corp. for the device "VENTLAB VERIFY II". The FDA issued a decision of Substantially Equivalent on February 11, 1999. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Ventlab Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1999
Date Received
January 12, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type