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FDA 510(k)

AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301

K-Number: K101641 · 2011-06-16

ApplicantAg Digital Technology Corp.
Decision Date2011-06-16
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 is the device name listed in this FDA 510(k) record. The listed applicant is Ag Digital Technology Corp.. It received FDA 510(k) clearance on 2011-06-16 under 510(k) number K101641. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301?

AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 is a medical device that received FDA 510(k) clearance on 2011-06-16. The listed applicant is Ag Digital Technology Corp.. The 510(k) number is K101641.

When did AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 receive FDA 510(k) clearance?

AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 received FDA 510(k) clearance on 2011-06-16, under 510(k) number K101641.

Who is the listed applicant for AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301?

The FDA 510(k) record lists Ag Digital Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301?

The FDA product code for AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 is LHQ.

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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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