The following data is part of a premarket notification filed by Orthotone Corp. with the FDA for Orthotone.
| Device ID | K872111 |
| 510k Number | K872111 |
| Device Name: | ORTHOTONE |
| Classification | Monitor, Eye Movement |
| Applicant | ORTHOTONE CORP. 201 EAST 28TH ST., SUITE 6-F New York, NY 10016 |
| Contact | John Orzuchowski |
| Correspondent | John Orzuchowski ORTHOTONE CORP. 201 EAST 28TH ST., SUITE 6-F New York, NY 10016 |
| Product Code | HLL |
| CFR Regulation Number | 886.1510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-01 |
| Decision Date | 1988-11-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORTHOTONE 72147235 0762289 Dead/Expired |
STATMASTER CORPORATION 1962-06-19 |