NOVA CO-OXIMETER ANALYZER— 510(k) K955013
Substantially EquivalentNova Biomedical Corp.
FDA 510(k) clearance K955013 for NOVA CO-OXIMETER ANALYZER, Substantially Equivalent on 1996-04-25. Applicant: Nova Biomedical Corp.. Device class: 2.
Clearance details
- Applicant
- Nova Biomedical Corp.
- Product code
- Code GLY
- Device class
- Class 2
- Regulation
- 21 CFR 864.7500
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walham, MA, US
Recent devices under product code GLY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.