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FDA 510(k)

MOUTH TO MASK EMERGENCY VENTILATION

K-Number: K841429 · 1984-04-17

ApplicantO-Two Systems Intl., Inc.
Decision Date1984-04-17
Product CodeCAE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MOUTH TO MASK EMERGENCY VENTILATION is the device name listed in this FDA 510(k) record. The listed applicant is O-Two Systems Intl., Inc.. It received FDA 510(k) clearance on 1984-04-17 under 510(k) number K841429. The device is classified under product code CAE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOUTH TO MASK EMERGENCY VENTILATION?

MOUTH TO MASK EMERGENCY VENTILATION is a medical device that received FDA 510(k) clearance on 1984-04-17. The listed applicant is O-Two Systems Intl., Inc.. The 510(k) number is K841429.

When did MOUTH TO MASK EMERGENCY VENTILATION receive FDA 510(k) clearance?

MOUTH TO MASK EMERGENCY VENTILATION received FDA 510(k) clearance on 1984-04-17, under 510(k) number K841429.

Who is the listed applicant for MOUTH TO MASK EMERGENCY VENTILATION?

The FDA 510(k) record lists O-Two Systems Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOUTH TO MASK EMERGENCY VENTILATION?

The FDA product code for MOUTH TO MASK EMERGENCY VENTILATION is CAE.

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Related Devices (Code: CAE)

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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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