KENTEMP— 510(k) K953465

Substantially Equivalent

Kentron Health Care, Inc.

FDA 510(k) clearance K953465 for KENTEMP, Substantially Equivalent on 1995-12-15. Applicant: Kentron Health Care, Inc.. Device class: 2.

Clearance details

Applicant: Kentron Health Care, Inc.
Product code: Code FLK
Device class: Class 2
Regulation: 21 CFR 880.2920
Advisory panel: General Hospital
Date received: 1995-07-24
Decision date: 1995-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hollywood, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FLK

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K960224 — GERATHERM MERCUIRY FREE CLINICAL THERMOMETER1996-03-25
K942483 — CLINICAL GLASS THERMOMETER1995-03-28
K941673 — MEDIAID UNIVERSAL THERMOMETER1994-08-25
K940380 — AMG MED BRAND CLINICAL GLASS THERMOMETER1994-05-04

More clearances from Kentron Health Care, Inc.

K030693 — KENTEX DISPOSABLE VAGINAL SPECULUM2003-08-27
K971917 — KENTRON'S ISOLATION GOWN1997-09-19
K972410 — IMPERVIOUS ISOLATION GOWN1997-09-19
K953914 — KENTEX1995-11-06
K953830 — KENSORB1995-10-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.