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FDA 510(k)

INFANT CARDIAC ARRAY

K-Number: K083539 · 2009-04-03

ApplicantAdvanced Imaging Research, Inc.
Decision Date2009-04-03
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFANT CARDIAC ARRAY is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Imaging Research, Inc.. It received FDA 510(k) clearance on 2009-04-03 under 510(k) number K083539. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFANT CARDIAC ARRAY?

INFANT CARDIAC ARRAY is a medical device that received FDA 510(k) clearance on 2009-04-03. The listed applicant is Advanced Imaging Research, Inc.. The 510(k) number is K083539.

When did INFANT CARDIAC ARRAY receive FDA 510(k) clearance?

INFANT CARDIAC ARRAY received FDA 510(k) clearance on 2009-04-03, under 510(k) number K083539.

Who is the listed applicant for INFANT CARDIAC ARRAY?

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

What is the FDA product code for INFANT CARDIAC ARRAY?

The FDA product code for INFANT CARDIAC ARRAY is MOS.

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Other records listing Advanced Imaging Research, 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.

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Related Devices (Code: MOS)

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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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