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FDA 510(k)

PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480

K-Number: K912112 · 1991-06-17

ApplicantTomey Corporation USA
Decision Date1991-06-17
Product CodeLQJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 is the device name listed in this FDA 510(k) record. The listed applicant is Tomey Corporation USA. It received FDA 510(k) clearance on 1991-06-17 under 510(k) number K912112. The device is classified under product code LQJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480?

PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 is a medical device that received FDA 510(k) clearance on 1991-06-17. The listed applicant is Tomey Corporation USA. The 510(k) number is K912112.

When did PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 receive FDA 510(k) clearance?

PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 received FDA 510(k) clearance on 1991-06-17, under 510(k) number K912112.

Who is the listed applicant for PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480?

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

What is the FDA product code for PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480?

The FDA product code for PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 is LQJ.

Other records listing Tomey Corporation USA 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.

K971953CONFOSCANK971685IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEMK961805TOMEY DTL ELECTRODEK932571TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4K945959VIDEO VISION ANALYZER (VIVA), VRB 100K944910TOMEY EM-1000 SPECULAR MICROSCOPE

View all 9 devices →

Related Devices (Code: LQJ)

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.

K163632Katalyst Cyclophotocoagulation ProbeKatalyst Surgical, LLCK931356SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTORSorenson Laboratories, Inc.K921414TROKEL /3 GONIO LASER LENSOcular Instruments, Inc.K893731SHIELDS T.C. LASER LENSOcular Instruments, Inc.K884694MQL 20 ND:YAG OPHTHALMIC LASERCalifornia Laboratories, Inc.K883719INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEMBiophysic Medical, Inc.

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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