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FDA 510(k)

ENDOTRACHEAL TUBE STYLET

K-Number: K921128 · 1992-06-02

ApplicantEastmed Enterprises, Inc.
Decision Date1992-06-02
Product CodeBSR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENDOTRACHEAL TUBE STYLET is the device name listed in this FDA 510(k) record. The listed applicant is Eastmed Enterprises, Inc.. It received FDA 510(k) clearance on 1992-06-02 under 510(k) number K921128. 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 ENDOTRACHEAL TUBE STYLET?

ENDOTRACHEAL TUBE STYLET is a medical device that received FDA 510(k) clearance on 1992-06-02. The listed applicant is Eastmed Enterprises, Inc.. The 510(k) number is K921128.

When did ENDOTRACHEAL TUBE STYLET receive FDA 510(k) clearance?

ENDOTRACHEAL TUBE STYLET received FDA 510(k) clearance on 1992-06-02, under 510(k) number K921128.

Who is the listed applicant for ENDOTRACHEAL TUBE STYLET?

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

What is the FDA product code for ENDOTRACHEAL TUBE STYLET?

The FDA product code for ENDOTRACHEAL TUBE STYLET is BSR.

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Other records listing Eastmed Enterprises, 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.

K922019LARYNGOSCOPE RIGIDK914741AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIEDK903618ROBERTAZZI NASOPHARYNGEAL AIRWAYK901489MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE)K890342AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)K884584TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS

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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 IncorporatedK962361TRACHLIGHT STYLET AND TRACHEAL LIGHTWANDLaerdal Medical Corp.K954771TRACHLIGHT 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.

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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