The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Dynamic Cardiac Phantom 74-347.
Device ID | K853756 |
510k Number | K853756 |
Device Name: | DYNAMIC CARDIAC PHANTOM 74-347 |
Classification | Holder, Radiographic Cassette, Wall-mounted |
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 | IXY |
CFR Regulation Number | 892.1880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-09 |
Decision Date | 1985-10-29 |