The following data is part of a premarket notification filed by R3 X-ray L.l.c with the FDA for Radgil2.
Device ID | K201177 |
510k Number | K201177 |
Device Name: | RadGil2 |
Classification | Irradiator, Blood To Prevent Graft Versus Host Disease |
Applicant | R3 X-Ray L.L.C 2730 E. Broadway BLVD STE 160 Tucson, AZ 85716 |
Contact | Robert Hase |
Correspondent | Robert Hase R3 X-Ray L.L.C 2730 E. Broadway BLVD STE 160 Tucson, AZ 85716 |
Product Code | MOT |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-05-01 |
Decision Date | 2020-08-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B850033600040 | K201177 | 000 |