510(k) K904954

CONDOR DIGITAL INFLATION SYRINGE by Professional Medical Services — Product Code MAV

K904954 is an FDA 510(k) premarket notification submitted by Professional Medical Services for the device "CONDOR DIGITAL INFLATION SYRINGE". The FDA issued a decision of Substantially Equivalent on January 16, 1991. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Professional Medical Services has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1991
Date Received
November 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Balloon Inflation
Device Class
Class II
Regulation Number
870.1650
Review Panel
CV
Submission Type