DeviceClearance

Ultrasound System 2300— 510(k) K223830

Substantially Equivalent

Bk Medical Aps

FDA 510(k) clearance K223830 for Ultrasound System 2300, Substantially Equivalent on 2023-04-11. Applicant: Bk Medical Aps. Device class: 2.

Clearance details

Applicant
Bk Medical Aps
Product code
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
Herlev, DK
Download summary PDFView on FDA.gov ↗

Recent devices under product code IYN

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More clearances from Bk Medical Aps

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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 K223830

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223830.

Data sourced from openFDA. This site is unofficial and independent of the FDA.