The following data is part of a premarket notification filed by Adaptive Video, Inc. with the FDA for Ad/v Imageplex(tm).
Device ID | K943158 |
510k Number | K943158 |
Device Name: | AD/V IMAGEPLEX(TM) |
Classification | System, Digital Image Communications, Radiological |
Applicant | ADAPTIVE VIDEO, INC. 75 DIGITAL DR. Novato, CA 94949 |
Contact | Lisa S Jones |
Correspondent | Lisa S Jones ADAPTIVE VIDEO, INC. 75 DIGITAL DR. Novato, CA 94949 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-01 |
Decision Date | 1994-11-22 |