R 302— 510(k) K946320

Substantially Equivalent

Ralco S.R.L.

FDA 510(k) clearance K946320 for R 302, Substantially Equivalent on 1995-05-11. Applicant: Ralco S.R.L.. Device class: 2.

Clearance details

Applicant: Ralco S.R.L.
Product code: Code KPW
Device class: Class 2
Regulation: 21 CFR 892.1610
Advisory panel: Radiology
Date received: 1994-12-28
Decision date: 1995-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Italy, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPW

K093596 — LUMOS, MODEL R 72B2010-01-12
K062788 — COLLIMATOR, MODEL M-382006-12-28
K030487 — R 722003-08-01
K954310 — BLA-800A1995-10-18
K914184 — P2020-8-0 BEAM-LIMITING DEVICE1991-11-27

More clearances from Ralco S.R.L.

K110856 — RALCO2011-08-10
K091517 — RALCO, MODEL R225 ACS2009-07-14
K083029 — MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR2008-12-05
K072780 — MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR2007-11-26

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