The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for Linear Tomographic System: Pmt 6000.
Device ID | K942175 |
510k Number | K942175 |
Device Name: | LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 |
Classification | System, X-ray, Tomographic |
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 | IZF |
CFR Regulation Number | 892.1740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-04 |
Decision Date | 1994-08-17 |