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FDA 510(k)

EasyOne Sky Spirometer

K-Number: K230178 · 2023-10-19

ApplicantNdd Medizintechnik AG
Decision Date2023-10-19
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EasyOne Sky 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 2023-10-19 under 510(k) number K230178. 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 Sky Spirometer?

EasyOne Sky Spirometer is a medical device that received FDA 510(k) clearance on 2023-10-19. The listed applicant is Ndd Medizintechnik AG. The 510(k) number is K230178.

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

EasyOne Sky Spirometer received FDA 510(k) clearance on 2023-10-19, under 510(k) number K230178.

Who is the listed applicant for EasyOne Sky 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 Sky Spirometer?

The FDA product code for EasyOne Sky 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.

K221250EasyOne FilterK161534EasyOne Pro Respiratory Analysis SystemK161536EasyOne Air Spirometer

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 USAK222525Alveoair Digital SpirometerRoundworks Technologies Private LimitedK222443Air Smart Extra SpirometerFeellife Health, Inc.

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.

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