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FDA 510(k)

HYGROSTER

K-Number: K941585 · 1994-04-19

ApplicantMallinckrodt Medical
Decision Date1994-04-19
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HYGROSTER is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical. It received FDA 510(k) clearance on 1994-04-19 under 510(k) number K941585. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYGROSTER?

HYGROSTER is a medical device that received FDA 510(k) clearance on 1994-04-19. The listed applicant is Mallinckrodt Medical. The 510(k) number is K941585.

When did HYGROSTER receive FDA 510(k) clearance?

HYGROSTER received FDA 510(k) clearance on 1994-04-19, under 510(k) number K941585.

Who is the listed applicant for HYGROSTER?

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

What is the FDA product code for HYGROSTER?

The FDA product code for HYGROSTER is BYD.

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Other records listing Mallinckrodt Medical 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.

K082520SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBESK051416SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULAK972258HI-CARE CLOSED SUCTION SYSTEMK971267SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUFK963732PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULAK955721CUFFED OROPHARYNGEAL AIRWAY (COPA)

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Related Devices (Code: BYD)

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.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor ABK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, 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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