The following data is part of a premarket notification filed by Regulatory Management Services with the FDA for Mini Imager.
Device ID | K950423 |
510k Number | K950423 |
Device Name: | MINI IMAGER |
Classification | Camera, Multi Format, 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 | LMC |
CFR Regulation Number | 892.2040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-02 |
Decision Date | 1995-05-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MINI IMAGER 74362908 not registered Dead/Abandoned |
Aspect Electronics, Inc. 1993-03-01 |