EASI ECG ALGORITHM— 510(k) K033513
Substantially EquivalentPhilips Medical Systems
FDA 510(k) clearance K033513 for EASI ECG ALGORITHM, Substantially Equivalent on 2004-01-15. Applicant: Philips Medical Systems. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems
- Product code
- Code DRW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2350
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Andover, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.