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FDA 510(k)

V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS

K-Number: K102985 · 2011-04-05

ApplicantRespironics, Inc.
Decision Date2011-04-05
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2011-04-05 under 510(k) number K102985. 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 WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS?

V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS is a medical device that received FDA 510(k) clearance on 2011-04-05. The listed applicant is Respironics, Inc.. The 510(k) number is K102985.

When did V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS receive FDA 510(k) clearance?

V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS received FDA 510(k) clearance on 2011-04-05, under 510(k) number K102985.

Who is the listed applicant for V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS?

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

What is the FDA product code for V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS?

The FDA product code for V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS is MNT.

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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.

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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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