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FDA 510(k)

INFANT ARRAY

K-Number: K113365 · 2012-03-29

ApplicantAdvanced Imaging Research Dba Sree Medical Systems
Decision Date2012-03-29
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFANT ARRAY is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Imaging Research Dba Sree Medical Systems. It received FDA 510(k) clearance on 2012-03-29 under 510(k) number K113365. 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 ARRAY?

INFANT ARRAY is a medical device that received FDA 510(k) clearance on 2012-03-29. The listed applicant is Advanced Imaging Research Dba Sree Medical Systems. The 510(k) number is K113365.

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

INFANT ARRAY received FDA 510(k) clearance on 2012-03-29, under 510(k) number K113365.

Who is the listed applicant for INFANT ARRAY?

The FDA 510(k) record lists Advanced Imaging Research Dba Sree Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFANT ARRAY?

The FDA product code for INFANT ARRAY is MOS.

Related Clinical Trials

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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Other records listing Advanced Imaging Research Dba Sree Medical Systems 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.

K161918SREE MRI Transport Incubator

Related Devices (Code: MOS)

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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