CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001— 510(k) K061046
Substantially EquivalentCardiomems, Inc.
FDA 510(k) clearance K061046 for CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001, Substantially Equivalent on 2006-10-12. Applicant: Cardiomems, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiomems, Inc.
- Product code
- Code NQH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2855
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Atlanta, GA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.