DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN— 510(k) K905488
Substantially EquivalentAusonics Pty , Ltd.
FDA 510(k) clearance K905488 for DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN, Substantially Equivalent on 1991-12-18. Applicant: Ausonics Pty , Ltd.. Device class: 1.
Clearance details
- Applicant
- Ausonics Pty , Ltd.
- Product code
- Code LMB
- Device class
- Class 1
- Regulation
- 21 CFR 892.2010
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
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