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FDA 510(k)

CellaVision DC-1, CellaVision DC-1 PPA

K-Number: K200595 · 2020-10-16

ApplicantCellaVision AB
Decision Date2020-10-16
Product CodeJOY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CellaVision DC-1, CellaVision DC-1 PPA is the device name listed in this FDA 510(k) record. The listed applicant is CellaVision AB. It received FDA 510(k) clearance on 2020-10-16 under 510(k) number K200595. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CellaVision DC-1, CellaVision DC-1 PPA?

CellaVision DC-1, CellaVision DC-1 PPA is a medical device that received FDA 510(k) clearance on 2020-10-16. The listed applicant is CellaVision AB. The 510(k) number is K200595.

When did CellaVision DC-1, CellaVision DC-1 PPA receive FDA 510(k) clearance?

CellaVision DC-1, CellaVision DC-1 PPA received FDA 510(k) clearance on 2020-10-16, under 510(k) number K200595.

Who is the listed applicant for CellaVision DC-1, CellaVision DC-1 PPA?

The FDA 510(k) record lists CellaVision AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CellaVision DC-1, CellaVision DC-1 PPA?

The FDA product code for CellaVision DC-1, CellaVision DC-1 PPA is JOY.

Other records listing CellaVision AB 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.

K171315Advanced RBC Application

Related Devices (Code: JOY)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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