510(k) K760246

ENDOTRACHEAL T CONNECTOR by Sherwood Medical Industries — Product Code BXA

K760246 is an FDA 510(k) premarket notification submitted by Sherwood Medical Industries for the device "ENDOTRACHEAL T CONNECTOR". The FDA issued a decision of Substantially Equivalent on August 4, 1976. The device falls under product code BXA (Analyzer, Gas, Water Vapor, Gaseous-Phase), a Class I device regulated under 21 CFR 868.1975. Sherwood Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1976
Date Received
July 19, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Water Vapor, Gaseous-Phase
Device Class
Class I
Regulation Number
868.1975
Review Panel
AN
Submission Type