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FDA 510(k)

COMFORT EZ

K-Number: K122787 · 2012-12-06

ApplicantSimple Diagnostics, Inc.
Decision Date2012-12-06
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFORT EZ is the device name listed in this FDA 510(k) record. The listed applicant is Simple Diagnostics, Inc.. It received FDA 510(k) clearance on 2012-12-06 under 510(k) number K122787. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORT EZ?

COMFORT EZ is a medical device that received FDA 510(k) clearance on 2012-12-06. The listed applicant is Simple Diagnostics, Inc.. The 510(k) number is K122787.

When did COMFORT EZ receive FDA 510(k) clearance?

COMFORT EZ received FDA 510(k) clearance on 2012-12-06, under 510(k) number K122787.

Who is the listed applicant for COMFORT EZ?

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

What is the FDA product code for COMFORT EZ?

The FDA product code for COMFORT EZ is FMF.

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 Simple Diagnostics, 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.

K120921CLEVER CHOICEK121632COMFORT EZ

Related Devices (Code: FMF)

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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