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)

ScanX Barrier Envelopes

K-Number: K190949 · 2019-07-26

ApplicantAir Techniques, Inc.
Decision Date2019-07-26
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ScanX Barrier Envelopes is the device name listed in this FDA 510(k) record. The listed applicant is Air Techniques, Inc.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K190949. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ScanX Barrier Envelopes?

ScanX Barrier Envelopes is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Air Techniques, Inc.. The 510(k) number is K190949.

When did ScanX Barrier Envelopes receive FDA 510(k) clearance?

ScanX Barrier Envelopes received FDA 510(k) clearance on 2019-07-26, under 510(k) number K190949.

Who is the listed applicant for ScanX Barrier Envelopes?

The FDA 510(k) record lists Air Techniques, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ScanX Barrier Envelopes?

The FDA product code for ScanX Barrier Envelopes is PEM.

Other records listing Air Techniques, Inc. 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.

K191623ScanX Touch/ScanX Duo Touch

Related Devices (Code: PEM)

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.

K250735Dental Barrier and SleevesFomed Industries, Inc.K250606Dental Barrier and SleevesYueying Medical Instruments (Langfang) Co., Ltd.K242435Dental Barrier and SleevesWellmed Dental Medical Supply Co., Ltd.K233918Dental Barrier and SleevesYongqing Huaguan Dental Instruments FactoryK220662Disposable Barrier SleevesPremium Plus (Dongguan) LimitedK211026Minitube Dentasleeve Protective Barrier SleevesMinitube AB

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.

↑