PCWP Analysis Software— 510(k) DEN250057
UnknownCardiosense, Inc.
FDA 510(k) clearance DEN250057 for PCWP Analysis Software, Unknown on 2026-05-22. Applicant: Cardiosense, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiosense, Inc.
- Product code
- Code SIF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Chicago, IL, US
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