The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for Electrophysiology (ep) Table Ep 2000 Series.
Device ID | K931724 |
510k Number | K931724 |
Device Name: | ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES |
Classification | Table, Radiologic |
Applicant | CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
Contact | Oscar Khutoryansky |
Correspondent | Oscar Khutoryansky CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
Product Code | KXJ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-24 |
Decision Date | 1993-06-14 |