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)

Airworks Nebulizer pe1200m

K-Number: K162041 · 2017-05-02

ApplicantConvexity Scientific, LLC
Decision Date2017-05-02
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Airworks Nebulizer pe1200m is the device name listed in this FDA 510(k) record. The listed applicant is Convexity Scientific, LLC. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K162041. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Airworks Nebulizer pe1200m?

Airworks Nebulizer pe1200m is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Convexity Scientific, LLC. The 510(k) number is K162041.

When did Airworks Nebulizer pe1200m receive FDA 510(k) clearance?

Airworks Nebulizer pe1200m received FDA 510(k) clearance on 2017-05-02, under 510(k) number K162041.

Who is the listed applicant for Airworks Nebulizer pe1200m?

The FDA 510(k) record lists Convexity Scientific, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Airworks Nebulizer pe1200m?

The FDA product code for Airworks Nebulizer pe1200m is CAF.

Related Devices (Code: CAF)

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.

K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd.K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)Joytech Healthcare Co. , Ltd.K250022HeroTracker SenseVoluntis

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.

↑