Versana Balance
K-Number: K191792 · 2019-08-09
Device Summary
Frequently Asked Questions
What is the Versana Balance?
Versana Balance is a medical device that received FDA 510(k) clearance on 2019-08-09. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K191792.
When did Versana Balance receive FDA 510(k) clearance?
Versana Balance received FDA 510(k) clearance on 2019-08-09, under 510(k) number K191792.
Who is the listed applicant for Versana Balance?
The FDA 510(k) record lists GE Medical Systems Ultrasound and Primary Care Diagnostics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Versana Balance?
The FDA product code for Versana Balance is IYN.
Other records listing GE Medical Systems Ultrasound and Primary Care Diagnostics 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.