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FDA 510(k)

KENTEMP

K-Number: K953465 · 1995-12-15

ApplicantKentron Health Care, Inc.
Decision Date1995-12-15
Product CodeFLK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KENTEMP is the device name listed in this FDA 510(k) record. The listed applicant is Kentron Health Care, Inc.. It received FDA 510(k) clearance on 1995-12-15 under 510(k) number K953465. The device is classified under product code FLK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENTEMP?

KENTEMP is a medical device that received FDA 510(k) clearance on 1995-12-15. The listed applicant is Kentron Health Care, Inc.. The 510(k) number is K953465.

When did KENTEMP receive FDA 510(k) clearance?

KENTEMP received FDA 510(k) clearance on 1995-12-15, under 510(k) number K953465.

Who is the listed applicant for KENTEMP?

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

What is the FDA product code for KENTEMP?

The FDA product code for KENTEMP is FLK.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kentron Health Care, 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.

K030693KENTEX DISPOSABLE VAGINAL SPECULUMK972410IMPERVIOUS ISOLATION GOWNK971917KENTRON'S ISOLATION GOWNK953914KENTEXK953830KENSORB

Related Devices (Code: FLK)

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.

K960185AMSINO CLINICAL THERMOMETERAmsia Intl., Inc.K960224GERATHERM MERCUIRY FREE CLINICAL THERMOMETERRg Ent., Inc.K942483CLINICAL GLASS THERMOMETERMakol Medical Instruments Corp.K941673MEDIAID UNIVERSAL THERMOMETERPolymedica Industries, Inc.K940380AMG MED BRAND CLINICAL GLASS THERMOMETERAmg Medical, Inc.K940394AMG MED BRAND CLINICAL GLASS THERMOMETERTechnolab Industries (Canada) , Ltd.

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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