GLY — Oximeter To Measure Hemoglobin Class II
FDA product code GLY covers "Oximeter To Measure Hemoglobin", a Class II medical device regulated under 21 CFR 864.7500. Submissions are reviewed by the Hematology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GLY
- Device Class
- Class II
- Regulation Number
- 864.7500
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K050014 | nir diagnostics | HEMONIR TM | May 5, 2005 |
| K993104 | nova biomedical | STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND | December 2, 1999 |
| K955013 | nova biomedical | NOVA CO-OXIMETER ANALYZER | April 25, 1996 |
| K952725 | radiometer america | MULTICHECK | February 20, 1996 |
| K895466 | avl scientific | AVL MODEL 912 CO-OXYLITE | November 6, 1989 |