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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Zebra Medical Vision, Ltd.. It received FDA 510(k) clearance on 2021-09-15 under 510(k) 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. The listed applicant is Zebra Medical Vision, Ltd.. The 510(k) number is K210085.

When did HealthCCSng receive FDA 510(k) clearance?

HealthCCSng received FDA 510(k) clearance on 2021-09-15, under 510(k) number K210085.

Who is the listed applicant for HealthCCSng?

The FDA 510(k) record lists Zebra Medical Vision, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HealthCCSng?

The FDA product code for HealthCCSng is JAK.

Other records listing Zebra Medical Vision, 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.

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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.

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