GUARDIAN AND ANDINO MODELS— 510(k) K932991

Substantially Equivalent

Coltemp, Inc.

FDA 510(k) clearance K932991 for GUARDIAN AND ANDINO MODELS, Substantially Equivalent on 1994-01-28. Applicant: Coltemp, Inc.. Device class: 2.

Clearance details

Applicant: Coltemp, Inc.
Product code: Code FLK
Device class: Class 2
Regulation: 21 CFR 880.2920
Advisory panel: General Hospital
Date received: 1993-06-18
Decision date: 1994-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FLK

K960185 — AMSINO CLINICAL THERMOMETER1996-03-28
K960224 — GERATHERM MERCUIRY FREE CLINICAL THERMOMETER1996-03-25
K953465 — KENTEMP1995-12-15
K942483 — CLINICAL GLASS THERMOMETER1995-03-28
K941673 — MEDIAID UNIVERSAL THERMOMETER1994-08-25

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