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FDA 510(k)

KLEAR-TEMP

K-Number: K926030 · 1994-02-24

ApplicantCas Medical Systems, Inc.
Decision Date1994-02-24
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KLEAR-TEMP is the device name listed in this FDA 510(k) record. The listed applicant is Cas Medical Systems, Inc.. It received FDA 510(k) clearance on 1994-02-24 under 510(k) number K926030. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLEAR-TEMP?

KLEAR-TEMP is a medical device that received FDA 510(k) clearance on 1994-02-24. The listed applicant is Cas Medical Systems, Inc.. The 510(k) number is K926030.

When did KLEAR-TEMP receive FDA 510(k) clearance?

KLEAR-TEMP received FDA 510(k) clearance on 1994-02-24, under 510(k) number K926030.

Who is the listed applicant for KLEAR-TEMP?

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

What is the FDA product code for KLEAR-TEMP?

The FDA product code for KLEAR-TEMP is FMT.

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Related Devices (Code: FMT)

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K243606Babyroo TN300Draeger Medical Systems, Inc.K230278Babyroo TN300Draeger Medical Systems, Inc.K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc.K201628Panda iRes Warmer, Giraffe WarmerGE HealthcareK200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableDeroyal Industries, Inc.K191425Hydro-Temp Neonatal Skin Temperature Probe CoverDeroyal Industries, Inc.

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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