510(k) K925263

MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT by Merit Medical Systems, Inc. — Product Code BZA

K925263 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT". The FDA issued a decision of Substantially Equivalent on February 2, 1993. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1993
Date Received
October 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Airway (Extension)
Device Class
Class I
Regulation Number
868.5810
Review Panel
AN
Submission Type