Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Vitalograph Model 6300 micro

K-Number: K160253 · 2016-08-26

ApplicantVitalograph (Ireland) , Ltd.
Decision Date2016-08-26
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Vitalograph Model 6300 micro is a medical device manufactured by Vitalograph (Ireland) , Ltd.. It received FDA 510(k) clearance on 2016-08-26 under approval number K160253. 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 Vitalograph Model 6300 micro?

Vitalograph Model 6300 micro is a medical device that received FDA 510(k) clearance on 2016-08-26. It is manufactured by Vitalograph (Ireland) , Ltd.. The 510(k) number is K160253.

When was Vitalograph Model 6300 micro approved by the FDA?

Vitalograph Model 6300 micro received FDA 510(k) clearance on 2016-08-26, under approval number K160253.

What company makes Vitalograph Model 6300 micro?

Vitalograph Model 6300 micro is manufactured by Vitalograph (Ireland) , Ltd..

What is the FDA product code for Vitalograph Model 6300 micro?

The FDA product code for Vitalograph Model 6300 micro is BZG.

Related Devices (Code: BZG)

K161676Q13 SPIROLYSER®Fim Medical K160116SpiroScoutGanshorn Medizin Electronic GmbH K150515IQSense Flow Sensor MouthpieceSdi Diagnostics, Inc. K163249GoSpiroMonitored Therapeutics, Inc. K161536EasyOne Air SpirometerNdd Medizintechnik AG K180011Pulmonx Chartis Tablet ConsolePulmonx Corporation

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.

↑