EDEC 90C— 510(k) K875342

Substantially Equivalent

Electromed Intl., Ltd.

FDA 510(k) clearance K875342 for EDEC 90C, Substantially Equivalent on 1988-01-29. Applicant: Electromed Intl., Ltd.. Device class: 1.

Clearance details

Applicant: Electromed Intl., Ltd.
Product code: Code IZO
Device class: Class 1
Regulation: 21 CFR 892.1700
Advisory panel: Radiology
Date received: 1987-12-30
Decision date: 1988-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZO

K954666 — MPH50, MPH65, AND MPH801995-11-24
K953582 — HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR1995-09-26
K953831 — N 800 HF1995-09-08
K952822 — SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G1995-07-12
K952265 — MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR1995-07-06

More clearances from Electromed Intl., Ltd.

K003688 — VIEW READING STATION2001-01-22
K000474 — VIEW NT2000-04-19
K990759 — VIEW COM1999-04-15
K974255 — CD-R STATION AND VRS-20001998-01-27
K971176 — VIEW ARCHIVING STATION1997-09-03

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