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FDA 510(k)

ROBERTAZZI NASOPHARYNGEAL AIRWAY

K-Number: K903618 · 1991-01-08

ApplicantEastmed Enterprises, Inc.
Decision Date1991-01-08
Product CodeBTQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ROBERTAZZI NASOPHARYNGEAL AIRWAY 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 1991-01-08 under 510(k) number K903618. The device is classified under product code BTQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROBERTAZZI NASOPHARYNGEAL AIRWAY?

ROBERTAZZI NASOPHARYNGEAL AIRWAY is a medical device that received FDA 510(k) clearance on 1991-01-08. The listed applicant is Eastmed Enterprises, Inc.. The 510(k) number is K903618.

When did ROBERTAZZI NASOPHARYNGEAL AIRWAY receive FDA 510(k) clearance?

ROBERTAZZI NASOPHARYNGEAL AIRWAY received FDA 510(k) clearance on 1991-01-08, under 510(k) number K903618.

Who is the listed applicant for ROBERTAZZI NASOPHARYNGEAL AIRWAY?

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 ROBERTAZZI NASOPHARYNGEAL AIRWAY?

The FDA product code for ROBERTAZZI NASOPHARYNGEAL AIRWAY is BTQ.

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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 RIGIDK921128ENDOTRACHEAL TUBE STYLETK914741AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIEDK901489MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE)K890342AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)K884584TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS

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Related Devices (Code: BTQ)

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.

K940320AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGSAd-Tech Medical Instrument CorpK921353NASOPHARYNGEAL AIRWAYCoast Medical Corp.K911784NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAYNorth American Sterilization & Packaging Co.K900456POLAMEDCO NASOPAHARYNGEAL AIRWAYPolamedco, Inc.K901279CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAYChatham IndustriesK883668SUNDERLAND NASAL TUBEExmoor Plastics , 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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