Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Leica Microsystems (Schweiz) AG. It received FDA 510(k) clearance on 2017-07-05 under approval 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. It is manufactured by Leica Microsystems (Schweiz) AG. The 510(k) number is K170239.

When was Leica FL560 approved by the FDA?

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

What company makes Leica FL560?

Leica FL560 is manufactured by Leica Microsystems (Schweiz) AG.

What is the FDA product code for Leica FL560?

The FDA product code for Leica FL560 is IZI.

Other Devices by Leica Microsystems (Schweiz) AG

K181537GLOW800 DEN180024Leica FL400

Related Devices (Code: IZI)

K151780CAAS WorkstationPie Medical Imaging BV K162991YELLOW 560 Fluorescence ModuleCarl Zeiss Meditec, AG K181537GLOW800Leica Microsystems (Schweiz) AG K180019CAAS WorkstationPie Medical Imaging BV K190772SURGICAL MICROSCOPE SYSTEM ORBEYE with IROlympus Medical Systems Corp. K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker)

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.

↑