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FDA 510(k)

NEOVO2R VENTILATORY

K-Number: K885243 · 1989-07-24

ApplicantNeomed
Decision Date1989-07-24
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEOVO2R VENTILATORY is the device name listed in this FDA 510(k) record. The listed applicant is Neomed. It received FDA 510(k) clearance on 1989-07-24 under 510(k) number K885243. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOVO2R VENTILATORY?

NEOVO2R VENTILATORY is a medical device that received FDA 510(k) clearance on 1989-07-24. The listed applicant is Neomed. The 510(k) number is K885243.

When did NEOVO2R VENTILATORY receive FDA 510(k) clearance?

NEOVO2R VENTILATORY received FDA 510(k) clearance on 1989-07-24, under 510(k) number K885243.

Who is the listed applicant for NEOVO2R VENTILATORY?

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

What is the FDA product code for NEOVO2R VENTILATORY?

The FDA product code for NEOVO2R VENTILATORY is BTM.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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