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FDA 510(k)

ACCUTEMP-PROBE

K-Number: K970686 · 1997-08-25

ApplicantKentec Medical, Inc.
Decision Date1997-08-25
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 1997-08-25 under 510(k) number K970686. 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 1997-08-25. The listed applicant is Kentec Medical, Inc.. The 510(k) number is K970686.

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

ACCUTEMP-PROBE received FDA 510(k) clearance on 1997-08-25, under 510(k) number K970686.

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-LEADK960080ACCUTEMP 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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