The following data is part of a premarket notification filed by Icare Finland Oy with the FDA for Icare Ic100.
Device ID | K153694 |
510k Number | K153694 |
Device Name: | Icare Ic100 |
Classification | Tonometer, Manual |
Applicant | Icare Finland Oy Ayritie 22 Vantaa, FI Fi-01510 |
Contact | Matti Tulikoura |
Correspondent | Matti Tulikoura Icare Finland Oy Ayritie 22 Vantaa, FI Fi-01510 |
Product Code | HKY |
CFR Regulation Number | 886.1930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-12-23 |
Decision Date | 2016-04-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06430033850473 | K153694 | 000 |