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FDA 510(k)

TENACORE OXYGEN BLENDER, MODEL TB-2000

K-Number: K081335 · 2008-11-14

ApplicantTenacore Holdings, Inc.
Decision Date2008-11-14
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TENACORE OXYGEN BLENDER, MODEL TB-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Tenacore Holdings, Inc.. It received FDA 510(k) clearance on 2008-11-14 under 510(k) number K081335. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENACORE OXYGEN BLENDER, MODEL TB-2000?

TENACORE OXYGEN BLENDER, MODEL TB-2000 is a medical device that received FDA 510(k) clearance on 2008-11-14. The listed applicant is Tenacore Holdings, Inc.. The 510(k) number is K081335.

When did TENACORE OXYGEN BLENDER, MODEL TB-2000 receive FDA 510(k) clearance?

TENACORE OXYGEN BLENDER, MODEL TB-2000 received FDA 510(k) clearance on 2008-11-14, under 510(k) number K081335.

Who is the listed applicant for TENACORE OXYGEN BLENDER, MODEL TB-2000?

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

What is the FDA product code for TENACORE OXYGEN BLENDER, MODEL TB-2000?

The FDA product code for TENACORE OXYGEN BLENDER, MODEL TB-2000 is BZR.

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Other records listing Tenacore Holdings, 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.

K053420TENACORE SP02 SENSORSK043075TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORINGK012041THE HAMMER MODEL H100

Related Devices (Code: BZR)

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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