510(k) K955013
- Device
- NOVA CO-OXIMETER ANALYZER
- Applicant
- NOVA BIOMEDICAL CORP.
- 510(k) number
- K955013
- Product code
- GLY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-25
- Date received
- 1995-11-01
- 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
- PAUL W MAC DONALD
- Address
- 200 Prospect St. Walham MA US 02454 02454
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 |
|---|---|---|---|
| K050014 | HEMONIR TM | Nir Diagnostics, Inc. | 2005-05-05 |
| 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 |
| K952725 | MULTICHECK | Radiometer America, Inc. | 1996-02-20 |
| K895466 | AVL MODEL 912 CO-OXYLITE | Avl Scientific Corp. | 1989-11-06 |
Legacy Summary#
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FDA Review#
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