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FDA 510(k)

ScanX Touch/ScanX Duo Touch

K-Number: K191623 · 2019-08-21

ApplicantAir Techniques, Inc.
Decision Date2019-08-21
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ScanX Touch/ScanX Duo Touch 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 2019-08-21 under 510(k) number K191623. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ScanX Touch/ScanX Duo Touch?

ScanX Touch/ScanX Duo Touch is a medical device that received FDA 510(k) clearance on 2019-08-21. The listed applicant is Air Techniques, Inc.. The 510(k) number is K191623.

When did ScanX Touch/ScanX Duo Touch receive FDA 510(k) clearance?

ScanX Touch/ScanX Duo Touch received FDA 510(k) clearance on 2019-08-21, under 510(k) number K191623.

Who is the listed applicant for ScanX Touch/ScanX Duo Touch?

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 Touch/ScanX Duo Touch?

The FDA product code for ScanX Touch/ScanX Duo Touch is MUH.

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.

K190949ScanX Barrier Envelopes

Related Devices (Code: MUH)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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