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FDA 510(k)

KNIGHTSTAR 335

K-Number: K973004 · 1998-07-16

ApplicantPuritan Bennett Corp.
Decision Date1998-07-16
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

KNIGHTSTAR 335 is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Bennett Corp.. It received FDA 510(k) clearance on 1998-07-16 under 510(k) number K973004. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KNIGHTSTAR 335?

KNIGHTSTAR 335 is a medical device that received FDA 510(k) clearance on 1998-07-16. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K973004.

When did KNIGHTSTAR 335 receive FDA 510(k) clearance?

KNIGHTSTAR 335 received FDA 510(k) clearance on 1998-07-16, under 510(k) number K973004.

Who is the listed applicant for KNIGHTSTAR 335?

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

What is the FDA product code for KNIGHTSTAR 335?

The FDA product code for KNIGHTSTAR 335 is MNT.

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Other records listing Puritan Bennett Corp. 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.

K063650VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840K053388MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTIONK023225PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWAREK022103PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEMK001646PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTIONK002001BREEZE SLEEPGEAR WITH DREAMSEAL

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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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