PHILIPS HERCEPTEST DIGITAL SCORE— 510(k) K130021
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K130021 for PHILIPS HERCEPTEST DIGITAL SCORE, Substantially Equivalent on 2013-09-19. Applicant: Philips Medical Systems Nederland B.V.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Nederland B.V.
- Product code
- Code OEO
- Device class
- Class 2
- Regulation
- 21 CFR 864.1860
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Best Noord-Brabant, NL
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Data sourced from openFDA. This site is unofficial and independent of the FDA.