The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Dar-2400-15b/30b.
Device ID | K955395 |
510k Number | K955395 |
Device Name: | DAR-2400-15B/30B |
Classification | System, X-ray, Angiographic |
Applicant | SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
Contact | Michael Fishback |
Correspondent | Michael Fishback SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
Product Code | IZI |
CFR Regulation Number | 892.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-24 |
Decision Date | 1995-12-11 |