Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)
K-Number: K201316 · 2021-02-26
Device Summary
Frequently Asked Questions
What is the Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)?
Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) is a medical device that received FDA 510(k) clearance on 2021-02-26. The listed applicant is Suzhou Peaksonic Medical Technology Co., Ltd.. The 510(k) number is K201316.
When did Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) receive FDA 510(k) clearance?
Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) received FDA 510(k) clearance on 2021-02-26, under 510(k) number K201316.
Who is the listed applicant for Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)?
The FDA 510(k) record lists Suzhou Peaksonic Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)?
The FDA product code for Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) is IYO.
Other records listing Suzhou Peaksonic Medical Technology 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: IYO)
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.