GoSpiro

FDA 510(k) K163249 · Monitored Therapeutics, Inc.

Substantially Equivalent

510(k) numberK163249

Submission

Device name
GoSpiro
Applicant
Monitored Therapeutics, Inc.
Dublin, OH, US
Received
November 18, 2016
Decision date
March 24, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BZG – Spirometer, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1840
Specialty
Anesthesiology

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Questions and answers

When was GoSpiro cleared by the FDA?

GoSpiro (K163249) received a 510(k) decision of Substantially Equivalent on March 24, 2017, 126 days after the submission was received.

What is the product code of K163249?

The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.