The following data is part of a premarket notification filed by Performance Ent. with the FDA for Dynavision 2000.
| Device ID | K911938 |
| 510k Number | K911938 |
| Device Name: | DYNAVISION 2000 |
| Classification | Recorder, Attention Task Performance |
| Applicant | PERFORMANCE ENT. 30 HAGERMAN BLVD. UNIONVILLE, ONTARIO, Canada, L3r 2a7, CA |
| Contact | Phil Jones |
| Correspondent | Phil Jones PERFORMANCE ENT. 30 HAGERMAN BLVD. UNIONVILLE, ONTARIO, Canada, L3r 2a7, CA |
| Product Code | LQD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-01 |
| Decision Date | 1991-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860011067641 | K911938 | 000 |
| 00860011067634 | K911938 | 000 |
| 00860011067627 | K911938 | 000 |
| 00860011067610 | K911938 | 000 |