BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR— 510(k) K110645
Substantially EquivalentSonosite,Inc.
FDA 510(k) clearance K110645 for BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR, Substantially Equivalent on 2011-06-03. Applicant: Sonosite,Inc.. Device class: 2.
Clearance details
- Applicant
- Sonosite,Inc.
- Product code
- Code DSB
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
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