510(k) K050014
- Device
- HEMONIR TM
- Applicant
- NIR DIAGNOSTICS, INC.
- 510(k) number
- K050014
- Product code
- GLY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-05-05
- Date received
- 2005-01-03
- Regulation
- 864.7500
- Classification name
- Oximeter To Measure Hemoglobin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CYNTHIA A SINCLAIR
- Address
- 49 Plain St. North Attleboro MA US 02760 02760
FDA Registration Numbers#
- 3004102403
- 3004193489
- 3023162659
- 3037000637
- 2431530
- 9610126
- 3006198300
- 3003795116
- 1219029
- 3007358963
- 1217183
- 3011979858
Source Documents#
Other 510(k) Records For Product Code GLY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993104 | STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR | Nova Biomedical Corp. | 1999-12-02 |
| K955013 | NOVA CO-OXIMETER ANALYZER | Nova Biomedical Corp. | 1996-04-25 |
| K952725 | MULTICHECK | Radiometer America, Inc. | 1996-02-20 |
| K895466 | AVL MODEL 912 CO-OXYLITE | Avl Scientific Corp. | 1989-11-06 |
Legacy Summary#
summary
FDA Review#
Decision Summary