Ultrasound System 2300

FDA 510(k) Premarket Notification · Submission K222441 · Applicant: Bk Medical Aps

Public Record 510(k) Submission Decision Date: 2022-12-07 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K222441.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K222441
Applicant / Sponsor
Device Name
Ultrasound System 2300
Product Code
IYN
Decision Date
2022-12-07
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
Radiology (RA)
Clearance Type
Traditional
Third Party Flag
N
Date Received
2022-08-12

Related Establishments / Registrations

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