Auto Positioning
K-Number: K192956 · 2020-01-16
ApplicantGe Hangwei Medical Systems Co., Ltd.
Decision Date2020-01-16
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Auto Positioning is a medical device manufactured by Ge Hangwei Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2020-01-16 under approval number K192956. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Auto Positioning?
Auto Positioning is a medical device that received FDA 510(k) clearance on 2020-01-16. It is manufactured by Ge Hangwei Medical Systems Co., Ltd.. The 510(k) number is K192956.
When was Auto Positioning approved by the FDA?
Auto Positioning received FDA 510(k) clearance on 2020-01-16, under approval number K192956.
What company makes Auto Positioning?
Auto Positioning is manufactured by Ge Hangwei Medical Systems Co., Ltd..
What is the FDA product code for Auto Positioning?
The FDA product code for Auto Positioning is JAK.
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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.