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FDA 510(k)

RESCUE BREATHER

K-Number: K940927 · 1994-10-14

ApplicantO-Two Systems Intl., Inc.
Decision Date1994-10-14
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESCUE BREATHER 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 1994-10-14 under 510(k) number K940927. 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 RESCUE BREATHER?

RESCUE BREATHER is a medical device that received FDA 510(k) clearance on 1994-10-14. The listed applicant is O-Two Systems Intl., Inc.. The 510(k) number is K940927.

When did RESCUE BREATHER receive FDA 510(k) clearance?

RESCUE BREATHER received FDA 510(k) clearance on 1994-10-14, under 510(k) number K940927.

Who is the listed applicant for RESCUE BREATHER?

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 RESCUE BREATHER?

The FDA product code for RESCUE BREATHER is CBP.

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Other records listing O-Two Systems Intl., Inc. as applicant

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Related Devices (Code: CBP)

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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