The following data is part of a premarket notification filed by Aspect Electronics, Inc. with the FDA for Aspect Acquisition Module (aam).
| Device ID | K954875 |
| 510k Number | K954875 |
| Device Name: | ASPECT ACQUISITION MODULE (AAM) |
| Classification | Digitizer, Image, 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 | LMA |
| CFR Regulation Number | 892.2030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-24 |
| Decision Date | 1996-01-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850677007037 | K954875 | 000 |