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FDA 510(k)

HALOGEN EXAM. LITE #48400

K-Number: K780628 · 1978-06-06

ApplicantWelch Allyn, Inc.
Decision Date1978-06-06
Product CodeKZF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HALOGEN EXAM. LITE #48400 is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 1978-06-06 under 510(k) number K780628. The device is classified under product code KZF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HALOGEN EXAM. LITE #48400?

HALOGEN EXAM. LITE #48400 is a medical device that received FDA 510(k) clearance on 1978-06-06. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K780628.

When did HALOGEN EXAM. LITE #48400 receive FDA 510(k) clearance?

HALOGEN EXAM. LITE #48400 received FDA 510(k) clearance on 1978-06-06, under 510(k) number K780628.

Who is the listed applicant for HALOGEN EXAM. LITE #48400?

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

What is the FDA product code for HALOGEN EXAM. LITE #48400?

The FDA product code for HALOGEN EXAM. LITE #48400 is KZF.

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Other records listing Welch Allyn, 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.

K243598Welch Allyn Connex® 360 (Multiple)K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)K223381iExaminer System with Panoptic PlusK212473Welch Allyn Connex Central StationK191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionK181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System

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Related Devices (Code: KZF)

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.

K954943NEVOSCOPENizar A. MullaniK952835WELCH ALLYN VIDEO EPISCOPEWelch Allyn, Inc.K945507H 5100, H 5200, H 5300Rudolf Riester GmbH & Co. KGK941869SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEGThe Lighthouse For the Blind, Inc.K936088WAVE FLUORESCENT MAGNIFIERBurton Medical Products Corp.K940284MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATIONMeddev International Corp.

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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