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FDA 510(k)

PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE

K-Number: K123470 · 2013-04-29

ApplicantPas Systems International, Inc.
Decision Date2013-04-29
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE is the device name listed in this FDA 510(k) record. The listed applicant is Pas Systems International, Inc.. It received FDA 510(k) clearance on 2013-04-29 under 510(k) number K123470. The device is classified under product code DJZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE?

PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE is a medical device that received FDA 510(k) clearance on 2013-04-29. The listed applicant is Pas Systems International, Inc.. The 510(k) number is K123470.

When did PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE receive FDA 510(k) clearance?

PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE received FDA 510(k) clearance on 2013-04-29, under 510(k) number K123470.

Who is the listed applicant for PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE?

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

What is the FDA product code for PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE?

The FDA product code for PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE is DJZ.

Related Clinical Trials

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Related Devices (Code: DJZ)

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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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