DeviceClearance

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X— 510(k) K220698

Substantially Equivalent

Panthera AB

FDA 510(k) clearance K220698 for Bambino 3, S3 and S3 Swing, U3 and U3 Light, X, Substantially Equivalent on 2023-02-16. Applicant: Panthera AB. Device class: 1.

Clearance details

Applicant
Panthera AB
Product code
Code IOR
Device class
Class 1
Regulation
21 CFR 890.3850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Stockholm, SE
Download summary PDFView on FDA.gov ↗

Recent devices under product code IOR

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Adverse events under product code IOR

product code IOR
Death
10
Injury
232
Other
2
Total
244

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.