FDA 510(k)

Asthma Monitor AM3

K-Number: K183479 · 2019-10-03

Decision Date2019-10-03

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Asthma Monitor AM3 is a medical device manufactured by Eresearch Technology. It received FDA 510(k) clearance on 2019-10-03 under approval number K183479. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Asthma Monitor AM3?

Asthma Monitor AM3 is a medical device that received FDA 510(k) clearance on 2019-10-03. It is manufactured by Eresearch Technology. The 510(k) number is K183479.

When was Asthma Monitor AM3 approved by the FDA?

Asthma Monitor AM3 received FDA 510(k) clearance on 2019-10-03, under approval number K183479.

What company makes Asthma Monitor AM3?

Asthma Monitor AM3 is manufactured by Eresearch Technology.

What is the FDA product code for Asthma Monitor AM3?

The FDA product code for Asthma Monitor AM3 is BZG.

Related Clinical Trials

NCT06321471 AeviceMD for Pediatric Asthma Management ACTIVE_NOT_RECRUITING NCT07500246 Advancing Diagnosis and Treatment of Pediatric Asthma RECRUITING NCT06734793 Wearable Electronic Breath Sound Sensing Device RECRUITING

Related Devices (Code: BZG)

K161676Q13 SPIROLYSER®Fim Medical K160116SpiroScoutGanshorn Medizin Electronic GmbH K160253Vitalograph Model 6300 microVitalograph (Ireland) , Ltd. K150515IQSense Flow Sensor MouthpieceSdi Diagnostics, Inc. K163249GoSpiroMonitored Therapeutics, Inc. K161536EasyOne Air SpirometerNdd Medizintechnik AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.