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FDA 510(k)

HEATMARKER TIME TEMPERATURE INDICATOR

K-Number: K063759 · 2007-08-15

ApplicantTemptime Corporation
Decision Date2007-08-15
Product CodeOCI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEATMARKER TIME TEMPERATURE INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Temptime Corporation. It received FDA 510(k) clearance on 2007-08-15 under 510(k) number K063759. The device is classified under product code OCI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEATMARKER TIME TEMPERATURE INDICATOR?

HEATMARKER TIME TEMPERATURE INDICATOR is a medical device that received FDA 510(k) clearance on 2007-08-15. The listed applicant is Temptime Corporation. The 510(k) number is K063759.

When did HEATMARKER TIME TEMPERATURE INDICATOR receive FDA 510(k) clearance?

HEATMARKER TIME TEMPERATURE INDICATOR received FDA 510(k) clearance on 2007-08-15, under 510(k) number K063759.

Who is the listed applicant for HEATMARKER TIME TEMPERATURE INDICATOR?

The FDA 510(k) record lists Temptime Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEATMARKER TIME TEMPERATURE INDICATOR?

The FDA product code for HEATMARKER TIME TEMPERATURE INDICATOR is OCI.

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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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