HP SONOS ULTRASOUND IMAGING SYSTEM— 510(k) K954028
Substantially EquivalentHewlett-Packard Co.
FDA 510(k) clearance K954028 for HP SONOS ULTRASOUND IMAGING SYSTEM, Substantially Equivalent on 1996-08-08. Applicant: Hewlett-Packard Co.. Device class: 2.
Clearance details
- Applicant
- Hewlett-Packard Co.
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Andover, MA, US
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Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
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 →
Recalls naming K954028
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K954028.
Data sourced from openFDA. This site is unofficial and independent of the FDA.