DIAGNOSTIC ULTRASOUND/URO-GYN UD 511— 510(k) K911166
Substantially EquivalentDiagnostic Ultrasound Corp.
FDA 510(k) clearance K911166 for DIAGNOSTIC ULTRASOUND/URO-GYN UD 511, Substantially Equivalent on 1991-08-15. Applicant: Diagnostic Ultrasound Corp.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Ultrasound Corp.
- Product code
- Code DXT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kirkland, WA, US
Recent devices under product code DXT
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- K253048 — High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
- K251788 — Extension tube
More clearances from Diagnostic Ultrasound Corp.
view allAdverse events under product code DXT
product code DXT- Death
- 39
- Injury
- 242
- Malfunction
- 463
- Other
- 3
- Total
- 747
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.