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FDA 510(k)

TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND

K-Number: K962361 · 1996-09-05

ApplicantLaerdal Medical Corp.
Decision Date1996-09-05
Product CodeBSR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND is the device name listed in this FDA 510(k) record. The listed applicant is Laerdal Medical Corp.. It received FDA 510(k) clearance on 1996-09-05 under 510(k) number K962361. The device is classified under product code BSR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND?

TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND is a medical device that received FDA 510(k) clearance on 1996-09-05. The listed applicant is Laerdal Medical Corp.. The 510(k) number is K962361.

When did TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND receive FDA 510(k) clearance?

TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND received FDA 510(k) clearance on 1996-09-05, under 510(k) number K962361.

Who is the listed applicant for TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND?

The FDA 510(k) record lists Laerdal Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND?

The FDA product code for TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND is BSR.

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Other records listing Laerdal Medical Corp. 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.

K001742RESUSCI INFLATE-A-SHIELD CPR BARRIERK954771TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)K954609HEARTSTART 911K950698LSU 2000 PORTABLE SUCTION UNITK933048LAERDAL(TM) POCKET MASK, MODIFICATIONK896919HEARTSTART 3000

View all 11 devices →

Related Devices (Code: BSR)

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.

K162729Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft TipCook IncorporatedK954771TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)Laerdal Medical Corp.K943104MOLLOY INTUBATING STYLETTEMolloy Corp.K955238RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLERusch Intl.K953677LIGHTED FLEXGUIDE (MODIFICATION)Scientific Sales Intl., Inc.K952100RUSCH ENDOTRACHEAL TUBE STYLETRusch, 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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