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FDA 510(k)

LEICA FL800

K-Number: K080612 · 2008-05-09

ApplicantLeica Microsystems (Schweiz) AG
Decision Date2008-05-09
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LEICA FL800 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 2008-05-09 under 510(k) number K080612. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEICA FL800?

LEICA FL800 is a medical device that received FDA 510(k) clearance on 2008-05-09. The listed applicant is Leica Microsystems (Schweiz) AG. The 510(k) number is K080612.

When did LEICA FL800 receive FDA 510(k) clearance?

LEICA FL800 received FDA 510(k) clearance on 2008-05-09, under 510(k) number K080612.

Who is the listed applicant for LEICA FL800?

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 FL800?

The FDA product code for LEICA FL800 is IZI.

Related Clinical Trials

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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.

K181537GLOW800K170239Leica FL560

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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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