The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Slit Camera Model 07-624.
Device ID | K851811 |
510k Number | K851811 |
Device Name: | SLIT CAMERA MODEL 07-624 |
Classification | Camera, Focal Spot, Radiographic |
Applicant | VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
Contact | Glasser |
Correspondent | Glasser VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
Product Code | IXH |
CFR Regulation Number | 892.1940 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-26 |
Decision Date | 1985-05-28 |