The following data is part of a premarket notification filed by Ocusense, Inc. with the FDA for Tearlab Osmolarity System.
| Device ID | K083184 |
| 510k Number | K083184 |
| Device Name: | TEARLAB OSMOLARITY SYSTEM |
| Classification | Osmolality Of Tears |
| Applicant | OCUSENSE, INC. 1835 MARKET ST., 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan OCUSENSE, INC. 1835 MARKET ST., 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | OND |
| CFR Regulation Number | 862.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-28 |
| Decision Date | 2009-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853539002034 | K083184 | 000 |