3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM— 510(k) K092853
Substantially EquivalentGalix Biomedical Instrumentation, Inc.
FDA 510(k) clearance K092853 for 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM, Substantially Equivalent on 2010-07-09. Applicant: Galix Biomedical Instrumentation, Inc..
Clearance details
- Applicant
- Galix Biomedical Instrumentation, Inc.
- Product code
- Code MLO
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami Beach, FL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.