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FDA 510(k)

CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)

K-Number: K081330 · 2009-03-06

ApplicantO-Two Medical Technologies, Inc.
Decision Date2009-03-06
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) is the device name listed in this FDA 510(k) record. The listed applicant is O-Two Medical Technologies, Inc.. It received FDA 510(k) clearance on 2009-03-06 under 510(k) number K081330. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)?

CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) is a medical device that received FDA 510(k) clearance on 2009-03-06. The listed applicant is O-Two Medical Technologies, Inc.. The 510(k) number is K081330.

When did CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) receive FDA 510(k) clearance?

CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) received FDA 510(k) clearance on 2009-03-06, under 510(k) number K081330.

Who is the listed applicant for CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)?

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

What is the FDA product code for CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)?

The FDA product code for CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) is BTL.

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Other records listing O-Two Medical Technologies, Inc. as applicant

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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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