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FDA 510(k)

LIFEGUARD VENT MASK

K-Number: K883383 · 1988-11-21

ApplicantBreath of Life, Inc.
Decision Date1988-11-21
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LIFEGUARD VENT MASK is the device name listed in this FDA 510(k) record. The listed applicant is Breath of Life, Inc.. It received FDA 510(k) clearance on 1988-11-21 under 510(k) number K883383. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFEGUARD VENT MASK?

LIFEGUARD VENT MASK is a medical device that received FDA 510(k) clearance on 1988-11-21. The listed applicant is Breath of Life, Inc.. The 510(k) number is K883383.

When did LIFEGUARD VENT MASK receive FDA 510(k) clearance?

LIFEGUARD VENT MASK received FDA 510(k) clearance on 1988-11-21, under 510(k) number K883383.

Who is the listed applicant for LIFEGUARD VENT MASK?

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

What is the FDA product code for LIFEGUARD VENT MASK?

The FDA product code for LIFEGUARD VENT MASK is CBP.

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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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