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FDA 510(k)

V60 VENTILATOR, MODEL V8000

K-Number: K082660 · 2009-01-09

ApplicantRespironics California, Inc.
Decision Date2009-01-09
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

V60 VENTILATOR, MODEL V8000 is the device name listed in this FDA 510(k) record. The listed applicant is Respironics California, Inc.. It received FDA 510(k) clearance on 2009-01-09 under 510(k) number K082660. 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 V60 VENTILATOR, MODEL V8000?

V60 VENTILATOR, MODEL V8000 is a medical device that received FDA 510(k) clearance on 2009-01-09. The listed applicant is Respironics California, Inc.. The 510(k) number is K082660.

When did V60 VENTILATOR, MODEL V8000 receive FDA 510(k) clearance?

V60 VENTILATOR, MODEL V8000 received FDA 510(k) clearance on 2009-01-09, under 510(k) number K082660.

Who is the listed applicant for V60 VENTILATOR, MODEL V8000?

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

What is the FDA product code for V60 VENTILATOR, MODEL V8000?

The FDA product code for V60 VENTILATOR, MODEL V8000 is MNT.

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Other records listing Respironics California, 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.

K110083V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODEK110795V200 INTELLI-TRAK OPTIONK102054V200 VENTILATORK072450ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000K071212ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000K051262ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000

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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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