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FDA 510(k)

Leica FL560

K-Number: K170239 · 2017-07-05

ApplicantLeica Microsystems (Schweiz) AG
Decision Date2017-07-05
Product CodeIZI
Advisory CommitteeRA
DecisionUnknown

Device Summary

Leica FL560 is the device name listed in this FDA 510(k) record. The listed applicant is Leica Microsystems (Schweiz) AG. It received FDA 510(k) clearance on 2017-07-05 under 510(k) number K170239. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Leica FL560?

Leica FL560 is a medical device that received FDA 510(k) clearance on 2017-07-05. The listed applicant is Leica Microsystems (Schweiz) AG. The 510(k) number is K170239.

When did Leica FL560 receive FDA 510(k) clearance?

Leica FL560 received FDA 510(k) clearance on 2017-07-05, under 510(k) number K170239.

Who is the listed applicant for Leica FL560?

The FDA 510(k) record lists Leica Microsystems (Schweiz) AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Leica FL560?

The FDA product code for Leica FL560 is IZI.

Other records listing Leica Microsystems (Schweiz) AG 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.

K181537GLOW800

Related Devices (Code: IZI)

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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