FLEXT-THERM— 510(k) K781916

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K781916 for FLEXT-THERM, Substantially Equivalent on 1979-02-02. Applicant: E-Z-Em, Inc.. Device class: 3.

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code KXZ
Device class: Class 3
Regulation: 21 CFR 884.2982
Advisory panel: Obstetrics/Gynecology
Date received: 1978-11-14
Decision date: 1979-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXZ

K851034 — NOVATHERM1985-09-27
K843124 — Q-SCAN THERMOGRAPHY SYSTEM1984-11-29
K832731 — BREAST & BODY HEALTH SYSTEM 20001984-01-30
K813547 — THERMASCAN1982-03-12
K770986 — FLEXI-THERM FILM1977-09-12

More clearances from E-Z-Em, Inc.

K071378 — MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES2007-06-13
K062449 — EMPOWERMR INJECTOR SYSTEM, MODEL 97302007-04-13
K063029 — EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/99002006-11-02
K053008 — E-Z-EM ENDOSCOPIC CO2 REGULATOR2005-12-27
K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725)2004-07-16

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