Syringe, CO2 Driven, Il Automatic Inject

FDA 510(k) K760448 · Instrumentation Laboratory CO

Substantially Equivalent

510(k) numberK760448

Submission

Device name
Syringe, CO2 Driven, Il Automatic Inject
Applicant
Instrumentation Laboratory CO
Mchenry, IL, US
Received
August 16, 1976
Decision date
August 27, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DXL – Injector, Indicator
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1660
Specialty
Cardiovascular

Other 510(k)s with product code DXL

510(k)DeviceApplicantDecision
K760500Tube, Heavy Glass Wall InjectionDXL · Traditional Unimetrics Corp.09/03/1976SE
K760066Tray, Iced Injectable (26420)DXL · Traditional Instrumentation Laboratory CO07/21/1976SE

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Questions and answers

When was Syringe, CO2 Driven, Il Automatic Inject cleared by the FDA?

Syringe, CO2 Driven, Il Automatic Inject (K760448) received a 510(k) decision of Substantially Equivalent on August 27, 1976, 11 days after the submission was received.

What is the product code of K760448?

The FDA product code is DXL – Injector, Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.1660.