Model Irc Passport Nebulizer

FDA 510(k) K914251 · Invacare Corp.

Substantially Equivalent

510(k) numberK914251

Submission

Device name
Model Irc Passport Nebulizer
Applicant
Invacare Corp.
Elyria, OH, US
Received
September 23, 1991
Decision date
January 24, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LAW – Theophylline Control Materials
Device class
Class I (low risk)
Regulation
21 CFR 862.3280
Specialty
Clinical Toxicology

Other 510(k)s with product code LAW

510(k)DeviceApplicantDecision
K920223Chem Chex Theophylline ControlLAW · Traditional Streck Laboratories, Inc.06/10/1992SE
K903924Biotrack Theophylline Quality ControlsLAW · Traditional Biotrack, Inc.09/17/1990SE
K871589Theophylline Fpia ControlsLAW · Traditional Sigma Chemical Co.06/17/1987SE

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Questions and answers

When was Model Irc Passport Nebulizer cleared by the FDA?

Model Irc Passport Nebulizer (K914251) received a 510(k) decision of Substantially Equivalent on January 24, 1992, 123 days after the submission was received.

What is the product code of K914251?

The FDA product code is LAW – Theophylline Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.