The following data is part of a premarket notification filed by Anschel Technology, Inc. with the FDA for Adherent Visual Stimulator Goggles.
| Device ID | K113785 |
| 510k Number | K113785 |
| Device Name: | ADHERENT VISUAL STIMULATOR GOGGLES |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | ANSCHEL TECHNOLOGY, INC. 261 MADISON AVENUE, 24TH FLOOR New York, NY 10016 |
| Contact | Glen Park |
| Correspondent | Glen Park ANSCHEL TECHNOLOGY, INC. 261 MADISON AVENUE, 24TH FLOOR New York, NY 10016 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-23 |
| Decision Date | 2012-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003291009 | K113785 | 000 |