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FDA 510(k)

Retina Workplace

K-Number: K170638 · 2017-06-21

ApplicantCarl Zeiss Meditec, AG
Decision Date2017-06-21
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Retina Workplace is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2017-06-21 under 510(k) number K170638. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Retina Workplace?

Retina Workplace is a medical device that received FDA 510(k) clearance on 2017-06-21. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K170638.

When did Retina Workplace receive FDA 510(k) clearance?

Retina Workplace received FDA 510(k) clearance on 2017-06-21, under 510(k) number K170638.

Who is the listed applicant for Retina Workplace?

The FDA 510(k) record lists Carl Zeiss Meditec, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Retina Workplace?

The FDA product code for Retina Workplace is NFJ.

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Related Devices (Code: NFJ)

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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