510(k) K760448

SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT by Instrumentation Laboratory CO — Product Code DXL

K760448 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT". The FDA issued a decision of Substantially Equivalent on August 27, 1976. The device falls under product code DXL (Injector, Indicator), a Class II device regulated under 21 CFR 870.1660. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1976
Date Received
August 16, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Indicator
Device Class
Class II
Regulation Number
870.1660
Review Panel
CV
Submission Type