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FDA 510(k)

ACCUTEMP PROBE

K-Number: K960080 · 1996-05-01

ApplicantKentec Medical, Inc.
Decision Date1996-05-01
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCUTEMP PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Kentec Medical, Inc.. It received FDA 510(k) clearance on 1996-05-01 under 510(k) number K960080. 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 ACCUTEMP PROBE?

ACCUTEMP PROBE is a medical device that received FDA 510(k) clearance on 1996-05-01. The listed applicant is Kentec Medical, Inc.. The 510(k) number is K960080.

When did ACCUTEMP PROBE receive FDA 510(k) clearance?

ACCUTEMP PROBE received FDA 510(k) clearance on 1996-05-01, under 510(k) number K960080.

Who is the listed applicant for ACCUTEMP PROBE?

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

What is the FDA product code for ACCUTEMP PROBE?

The FDA product code for ACCUTEMP PROBE is FMT.

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Other records listing Kentec 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.

K120272AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SETK100526AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBEK050443ACCU-LEADK970686ACCUTEMP-PROBEK853475GRAM-MA NEONATAL SC

Related Devices (Code: FMT)

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.

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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