The following data is part of a premarket notification filed by Oasis Medical, Inc. with the FDA for Tonoshield Tonometer Shield.
Device ID | K923877 |
510k Number | K923877 |
Device Name: | TONOSHIELD TONOMETER SHIELD |
Classification | Tonometer, Manual |
Applicant | OASIS MEDICAL, INC. 514 S. VERMONT AVE. Glendora, CA 91741 |
Contact | James Christensen |
Correspondent | James Christensen OASIS MEDICAL, INC. 514 S. VERMONT AVE. Glendora, CA 91741 |
Product Code | HKY |
CFR Regulation Number | 886.1930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-03 |
Decision Date | 1992-09-30 |