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FDA 510(k)

VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)

K-Number: K893170 · 1989-06-05

ApplicantKeeler Instruments, Inc.
Decision Date1989-06-05
Product CodeHJM
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) is the device name listed in this FDA 510(k) record. The listed applicant is Keeler Instruments, Inc.. It received FDA 510(k) clearance on 1989-06-05 under 510(k) number K893170. The device is classified under product code HJM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)?

VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) is a medical device that received FDA 510(k) clearance on 1989-06-05. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K893170.

When did VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) receive FDA 510(k) clearance?

VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) received FDA 510(k) clearance on 1989-06-05, under 510(k) number K893170.

Who is the listed applicant for VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)?

The FDA 510(k) record lists Keeler Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)?

The FDA product code for VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) is HJM.

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Other records listing Keeler Instruments, Inc. 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.

K181143Keeler TonoCare TonometerK112093CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTERK093298PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000K100500PSL CLASSIC SLIT LAMPK062412CRYOMATICK060822VANTAGE INDIRECT OPHTHALMOSCOPE

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Related Devices (Code: HJM)

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.

K972506INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATORInfinitech, Inc.K950529PEREGRINE DIFFUSION LIGHT PIPEPeregrine Surgical , Ltd.K945877WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHTWells Johnson Co.K931072HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBEHgm, Inc.K933445DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS)Storz Instrument Co.K940393PEREGRINE WIDE ANGLE LIGHT PIPEPeregrine Surgical , Ltd.

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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