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FDA 510(k)

SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE

K-Number: K101244 · 2010-11-18

ApplicantTruer Medical, Inc.
Decision Date2010-11-18
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Truer Medical, Inc.. It received FDA 510(k) clearance on 2010-11-18 under 510(k) number K101244. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE?

SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE is a medical device that received FDA 510(k) clearance on 2010-11-18. The listed applicant is Truer Medical, Inc.. The 510(k) number is K101244.

When did SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE receive FDA 510(k) clearance?

SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE received FDA 510(k) clearance on 2010-11-18, under 510(k) number K101244.

Who is the listed applicant for SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE?

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

What is the FDA product code for SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE?

The FDA product code for SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE is FLL.

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Other records listing Truer Medical, 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.

K092716ESOPHAGEAL STETHOSCOPE

Related Devices (Code: FLL)

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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