The following data is part of a premarket notification filed by Nir Diagnostics, Inc. with the FDA for Hemonir Tm.
| Device ID | K050014 |
| 510k Number | K050014 |
| Device Name: | HEMONIR TM |
| Classification | Oximeter To Measure Hemoglobin |
| Applicant | NIR DIAGNOSTICS, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia A Sinclair |
| Correspondent | Cynthia A Sinclair NIR DIAGNOSTICS, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | GLY |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-03 |
| Decision Date | 2005-05-05 |
| Summary: | summary |