The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon Tx-10 Tonometer.
Device ID | K963079 |
510k Number | K963079 |
Device Name: | CANON TX-10 TONOMETER |
Classification | Tonometer, Ac-powered |
Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
Contact | Glenn Impal |
Correspondent | Glenn Impal CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
Product Code | HKX |
CFR Regulation Number | 886.1930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-07 |
Decision Date | 1997-03-03 |
Summary: | summary |