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FDA 510(k)

INSTANT-X, MODELS 1713 & 128

K-Number: K042791 · 2005-07-01

ApplicantAnn Arbor Digital Devices
Decision Date2005-07-01
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INSTANT-X, MODELS 1713 & 128 is the device name listed in this FDA 510(k) record. The listed applicant is Ann Arbor Digital Devices. It received FDA 510(k) clearance on 2005-07-01 under 510(k) number K042791. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTANT-X, MODELS 1713 & 128?

INSTANT-X, MODELS 1713 & 128 is a medical device that received FDA 510(k) clearance on 2005-07-01. The listed applicant is Ann Arbor Digital Devices. The 510(k) number is K042791.

When did INSTANT-X, MODELS 1713 & 128 receive FDA 510(k) clearance?

INSTANT-X, MODELS 1713 & 128 received FDA 510(k) clearance on 2005-07-01, under 510(k) number K042791.

Who is the listed applicant for INSTANT-X, MODELS 1713 & 128?

The FDA 510(k) record lists Ann Arbor Digital Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSTANT-X, MODELS 1713 & 128?

The FDA product code for INSTANT-X, MODELS 1713 & 128 is MQB.

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Related Devices (Code: MQB)

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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.

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