SC-603 Twin Valve

FDA 510(k) K831486 · Instrumentation Industries, Inc.

Substantially Equivalent

510(k) numberK831486

Submission

Device name
SC-603 Twin Valve
Applicant
Instrumentation Industries, Inc.
Mchenry, IL, US
Received
May 10, 1983
Decision date
August 12, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BTM – Ventilator, Emergency, Manual (Resuscitator)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5915
Specialty
Anesthesiology
Life-sustaining
Yes

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Questions and answers

When was SC-603 Twin Valve cleared by the FDA?

SC-603 Twin Valve (K831486) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 94 days after the submission was received.

What is the product code of K831486?

The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.