FDA 510(k)

SREE MRI Transport Incubator

K-Number: K161918 · 2017-03-03

ApplicantAdvanced Imaging Research Dba Sree Medical Systems

Decision Date2017-03-03

Product CodeFPL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SREE MRI Transport Incubator 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 2017-03-03 under 510(k) number K161918. The device is classified under product code FPL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SREE MRI Transport Incubator?

SREE MRI Transport Incubator is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Advanced Imaging Research Dba Sree Medical Systems. The 510(k) number is K161918.

When did SREE MRI Transport Incubator receive FDA 510(k) clearance?

SREE MRI Transport Incubator received FDA 510(k) clearance on 2017-03-03, under 510(k) number K161918.

Who is the listed applicant for SREE MRI Transport Incubator?

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 SREE MRI Transport Incubator?

The FDA product code for SREE MRI Transport Incubator is FPL.

Related Devices (Code: FPL)

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.