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FDA 510(k)

CAREVENT CA AND DRA

K-Number: K051889 · 2005-08-30

ApplicantO-Two Medical Technologies, Inc.
Decision Date2005-08-30
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CAREVENT CA AND DRA 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 2005-08-30 under 510(k) number K051889. 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 CA AND DRA?

CAREVENT CA AND DRA is a medical device that received FDA 510(k) clearance on 2005-08-30. The listed applicant is O-Two Medical Technologies, Inc.. The 510(k) number is K051889.

When did CAREVENT CA AND DRA receive FDA 510(k) clearance?

CAREVENT CA AND DRA received FDA 510(k) clearance on 2005-08-30, under 510(k) number K051889.

Who is the listed applicant for CAREVENT CA AND DRA?

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 CA AND DRA?

The FDA product code for CAREVENT CA AND DRA is BTL.

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

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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Related Devices (Code: BTL)

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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