HERA W9, HERA W10 Diagnostic Ultrasound System
K-Number: K211824 · 2021-09-09
Device Summary
Frequently Asked Questions
What is the HERA W9, HERA W10 Diagnostic Ultrasound System?
HERA W9, HERA W10 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-09-09. The listed applicant is Samsung Medison Co., Ltd.. The 510(k) number is K211824.
When did HERA W9, HERA W10 Diagnostic Ultrasound System receive FDA 510(k) clearance?
HERA W9, HERA W10 Diagnostic Ultrasound System received FDA 510(k) clearance on 2021-09-09, under 510(k) number K211824.
Who is the listed applicant for HERA W9, HERA W10 Diagnostic Ultrasound System?
The FDA 510(k) record lists Samsung Medison Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HERA W9, HERA W10 Diagnostic Ultrasound System?
The FDA product code for HERA W9, HERA W10 Diagnostic Ultrasound System is IYN.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Samsung Medison Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: IYN)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.