CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080— 510(k) K082191
Substantially EquivalentCardiomems, Inc.
FDA 510(k) clearance K082191 for CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080, Substantially Equivalent on 2008-08-19. 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
- Abbreviated
- Location
- Atlanta, GA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.