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FDA 510(k)

BIPAP VISION VENTILATORY SUPPORT

K-Number: K982454 · 1998-11-03

ApplicantRespironics, Inc.
Decision Date1998-11-03
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

BIPAP VISION VENTILATORY SUPPORT is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1998-11-03 under 510(k) number K982454. 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 BIPAP VISION VENTILATORY SUPPORT?

BIPAP VISION VENTILATORY SUPPORT is a medical device that received FDA 510(k) clearance on 1998-11-03. The listed applicant is Respironics, Inc.. The 510(k) number is K982454.

When did BIPAP VISION VENTILATORY SUPPORT receive FDA 510(k) clearance?

BIPAP VISION VENTILATORY SUPPORT received FDA 510(k) clearance on 1998-11-03, under 510(k) number K982454.

Who is the listed applicant for BIPAP VISION VENTILATORY SUPPORT?

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 BIPAP VISION VENTILATORY SUPPORT?

The FDA product code for BIPAP VISION VENTILATORY SUPPORT is MNT.

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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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