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FDA 510(k)

SILICONE RUGGER DISPOSABLE YOKE-CPAP

K-Number: K834078 · 1983-12-27

ApplicantVesta, Inc.
Decision Date1983-12-27
Product CodeBTQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SILICONE RUGGER DISPOSABLE YOKE-CPAP is the device name listed in this FDA 510(k) record. The listed applicant is Vesta, Inc.. It received FDA 510(k) clearance on 1983-12-27 under 510(k) number K834078. 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 SILICONE RUGGER DISPOSABLE YOKE-CPAP?

SILICONE RUGGER DISPOSABLE YOKE-CPAP is a medical device that received FDA 510(k) clearance on 1983-12-27. The listed applicant is Vesta, Inc.. The 510(k) number is K834078.

When did SILICONE RUGGER DISPOSABLE YOKE-CPAP receive FDA 510(k) clearance?

SILICONE RUGGER DISPOSABLE YOKE-CPAP received FDA 510(k) clearance on 1983-12-27, under 510(k) number K834078.

Who is the listed applicant for SILICONE RUGGER DISPOSABLE YOKE-CPAP?

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

What is the FDA product code for SILICONE RUGGER DISPOSABLE YOKE-CPAP?

The FDA product code for SILICONE RUGGER DISPOSABLE YOKE-CPAP is BTQ.

Related Clinical Trials

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.

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Other records listing Vesta, 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.

K810960NASOPHARYNGEAL AIRWAYK7927193 WAY URETHRAL IRRIGATION CATHETERK792018SILICONE RUBBER-BI NASOPHARYNGEAL AIR

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.K903618ROBERTAZZI NASOPHARYNGEAL AIRWAYEastmed Enterprises, Inc.K900456POLAMEDCO NASOPAHARYNGEAL AIRWAYPolamedco, Inc.K901279CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAYChatham Industries

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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