Asthma Monitor AM3

FDA 510(k) K133722 · Eresearch Technology

Substantially Equivalent

510(k) numberK133722

Submission

Device name
Asthma Monitor AM3
Applicant
Eresearch Technology
Philadelphia, PA, US
Received
December 5, 2013
Decision date
May 8, 2014
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 Asthma Monitor AM3 cleared by the FDA?

Asthma Monitor AM3 (K133722) received a 510(k) decision of Substantially Equivalent on May 8, 2014, 154 days after the submission was received.

What is the product code of K133722?

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