The following data is part of a premarket notification filed by Regulatory Management Services with the FDA for Preview Teleimaging System.
Device ID | K950699 |
510k Number | K950699 |
Device Name: | PREVIEW TELEIMAGING SYSTEM |
Classification | System, Digital Image Communications, Radiological |
Applicant | REGULATORY MANAGEMENT SERVICES 16303 PANORAMIC WAY San Leandro, CA 94578 |
Contact | Gary J Allsebrook |
Correspondent | Gary J Allsebrook REGULATORY MANAGEMENT SERVICES 16303 PANORAMIC WAY San Leandro, CA 94578 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-15 |
Decision Date | 1995-05-03 |