The following data is part of a premarket notification filed by Aspect Electronics, Inc. with the FDA for Aspect Opticam.
Device ID | K962051 |
510k Number | K962051 |
Device Name: | ASPECT OPTICAM |
Classification | Camera, Multi Format, Radiological |
Applicant | ASPECT ELECTRONICS, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
Contact | Gary J Allsebrook |
Correspondent | Gary J Allsebrook ASPECT ELECTRONICS, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
Product Code | LMC |
CFR Regulation Number | 892.2040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-28 |
Decision Date | 1996-08-23 |
Summary: | summary |