The following data is part of a premarket notification filed by Bennett X-ray Corp. with the FDA for Bennett X-ray Tomography System.
Device ID | K945749 |
510k Number | K945749 |
Device Name: | BENNETT X-RAY TOMOGRAPHY SYSTEM |
Classification | System, X-ray, Tomographic |
Applicant | BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
Contact | Robert P Coe |
Correspondent | Robert P Coe BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
Product Code | IZF |
CFR Regulation Number | 892.1740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-23 |
Decision Date | 1995-02-15 |