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FDA 510(k)

KNIGHTSTAR 330 VENTILATOR

K-Number: K003075 · 2001-12-11

ApplicantMallinckrodt, Inc.
Decision Date2001-12-11
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

KNIGHTSTAR 330 VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt, Inc.. It received FDA 510(k) clearance on 2001-12-11 under 510(k) number K003075. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the KNIGHTSTAR 330 VENTILATOR?

KNIGHTSTAR 330 VENTILATOR is a medical device that received FDA 510(k) clearance on 2001-12-11. The listed applicant is Mallinckrodt, Inc.. The 510(k) number is K003075.

When did KNIGHTSTAR 330 VENTILATOR receive FDA 510(k) clearance?

KNIGHTSTAR 330 VENTILATOR received FDA 510(k) clearance on 2001-12-11, under 510(k) number K003075.

Who is the listed applicant for KNIGHTSTAR 330 VENTILATOR?

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

What is the FDA product code for KNIGHTSTAR 330 VENTILATOR?

The FDA product code for KNIGHTSTAR 330 VENTILATOR is MNT.

Related Clinical Trials

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Other records listing Mallinckrodt, 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.

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Related Devices (Code: MNT)

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.

K252182SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K242931HFT750UMekics Co., Ltd.K240779Vivo 3Breas Medical ABK233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.K230173Servo-air Lite Ventilator SystemMaquet Critical Care ABK213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, 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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