The following data is part of a premarket notification filed by S.a.i.e.p. S.r.l. with the FDA for Film Processor, Model Life Ray Pro 1000.
Device ID | K023801 |
510k Number | K023801 |
Device Name: | FILM PROCESSOR, MODEL LIFE RAY PRO 1000 |
Classification | Processor, Radiographic-film, Automatic |
Applicant | S.A.I.E.P. S.R.L. 2740-EAST FRONTAGE RD. Weatherford, OK 73096 -3658 |
Contact | Doug Hale |
Correspondent | Doug Hale S.A.I.E.P. S.R.L. 2740-EAST FRONTAGE RD. Weatherford, OK 73096 -3658 |
Product Code | IXW |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-14 |
Decision Date | 2003-02-12 |
Summary: | summary |