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 |