HealthCCSng
K-Number: K210085 · 2021-09-15
ApplicantZebra Medical Vision, Ltd.
Decision Date2021-09-15
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HealthCCSng is a medical device manufactured by Zebra Medical Vision, Ltd.. It received FDA 510(k) clearance on 2021-09-15 under approval number K210085. 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 HealthCCSng?
HealthCCSng is a medical device that received FDA 510(k) clearance on 2021-09-15. It is manufactured by Zebra Medical Vision, Ltd.. The 510(k) number is K210085.
When was HealthCCSng approved by the FDA?
HealthCCSng received FDA 510(k) clearance on 2021-09-15, under approval number K210085.
What company makes HealthCCSng?
HealthCCSng is manufactured by Zebra Medical Vision, Ltd..
What is the FDA product code for HealthCCSng?
The FDA product code for HealthCCSng is JAK.
Other Devices by Zebra Medical Vision, Ltd.
Related Devices (Code: JAK)
K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc.
K163213Revolution CTGe Medical Systems, LLC
K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.
K160723OnSight 3D Extremity SystemCarestream Health, Inc.
K161196SOMATOM DriveSiemens Medical Solutions USA, Inc.
K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.
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.