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

FDA 510(k)

EasyOne Air Spirometer

K-Number: K161536 · 2017-01-05

ApplicantNdd Medizintechnik AG
Decision Date2017-01-05
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EasyOne Air Spirometer is the device name listed in this FDA 510(k) record. The listed applicant is Ndd Medizintechnik AG. It received FDA 510(k) clearance on 2017-01-05 under 510(k) number K161536. 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 EasyOne Air Spirometer?

EasyOne Air Spirometer is a medical device that received FDA 510(k) clearance on 2017-01-05. The listed applicant is Ndd Medizintechnik AG. The 510(k) number is K161536.

When did EasyOne Air Spirometer receive FDA 510(k) clearance?

EasyOne Air Spirometer received FDA 510(k) clearance on 2017-01-05, under 510(k) number K161536.

Who is the listed applicant for EasyOne Air Spirometer?

The FDA 510(k) record lists Ndd Medizintechnik AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyOne Air Spirometer?

The FDA product code for EasyOne Air Spirometer is BZG.

Other records listing Ndd Medizintechnik AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230178EasyOne Sky SpirometerK221250EasyOne FilterK161534EasyOne Pro Respiratory Analysis System

Related Devices (Code: BZG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251777MESI mTABLET SPIROMesi D.O.O.K241843TD-7301 Spirometer (TD-7301)Gostar Co., Ltd.K231416Air Next (NVD-02)Nuvoair ABK230501Spirobank OxiMir Medical International Research USAK230178EasyOne Sky SpirometerNdd Medizintechnik AGK222525Alveoair Digital SpirometerRoundworks Technologies Private Limited

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.

↑