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FDA 510(k)

SOLID STATE LAMP [LED] HEADLIGHT

K-Number: K031549 · 2003-08-11

ApplicantWelch Allyn, Inc.
Decision Date2003-08-11
Product CodeFSR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SOLID STATE LAMP [LED] HEADLIGHT 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 2003-08-11 under 510(k) number K031549. The device is classified under product code FSR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLID STATE LAMP [LED] HEADLIGHT?

SOLID STATE LAMP [LED] HEADLIGHT is a medical device that received FDA 510(k) clearance on 2003-08-11. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K031549.

When did SOLID STATE LAMP [LED] HEADLIGHT receive FDA 510(k) clearance?

SOLID STATE LAMP [LED] HEADLIGHT received FDA 510(k) clearance on 2003-08-11, under 510(k) number K031549.

Who is the listed applicant for SOLID STATE LAMP [LED] HEADLIGHT?

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 SOLID STATE LAMP [LED] HEADLIGHT?

The FDA product code for SOLID STATE LAMP [LED] HEADLIGHT is FSR.

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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: FSR)

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.

K110528INTEGRA LED SURGICAL HEADLIGHT SYSTEMIntegra LifeSciences CorporationK031548LED HEADLIGHTWelch Allyn, Inc.K994362HEADLAMP HL2000.Angiolaz, 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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