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FDA 510(k)

ALPHA OMEGA DUAL COOLER-HEATER

K-Number: K001520 · 2000-11-22

ApplicantAlpha Omega, Inc.
Decision Date2000-11-22
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ALPHA OMEGA DUAL COOLER-HEATER is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Omega, Inc.. It received FDA 510(k) clearance on 2000-11-22 under 510(k) number K001520. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA OMEGA DUAL COOLER-HEATER?

ALPHA OMEGA DUAL COOLER-HEATER is a medical device that received FDA 510(k) clearance on 2000-11-22. The listed applicant is Alpha Omega, Inc.. The 510(k) number is K001520.

When did ALPHA OMEGA DUAL COOLER-HEATER receive FDA 510(k) clearance?

ALPHA OMEGA DUAL COOLER-HEATER received FDA 510(k) clearance on 2000-11-22, under 510(k) number K001520.

Who is the listed applicant for ALPHA OMEGA DUAL COOLER-HEATER?

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

What is the FDA product code for ALPHA OMEGA DUAL COOLER-HEATER?

The FDA product code for ALPHA OMEGA DUAL COOLER-HEATER is DWC.

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Related Devices (Code: DWC)

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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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