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 a medical device manufactured by Air Techniques, Inc.. It received FDA 510(k) clearance on 2019-07-26 under approval 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. It is manufactured by Air Techniques, Inc.. The 510(k) number is K190949.
When was ScanX Barrier Envelopes approved by the FDA?
ScanX Barrier Envelopes received FDA 510(k) clearance on 2019-07-26, under approval number K190949.
What company makes ScanX Barrier Envelopes?
ScanX Barrier Envelopes is manufactured by Air Techniques, Inc..
What is the FDA product code for ScanX Barrier Envelopes?
The FDA product code for ScanX Barrier Envelopes is PEM.
Other Devices by Air Techniques, Inc.
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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.