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FDA 510(k)

HELIO2 BLENDER

K-Number: K090781 · 2009-08-13

ApplicantPrecision Medical, Inc.
Decision Date2009-08-13
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HELIO2 BLENDER is the device name listed in this FDA 510(k) record. The listed applicant is Precision Medical, Inc.. It received FDA 510(k) clearance on 2009-08-13 under 510(k) number K090781. 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 HELIO2 BLENDER?

HELIO2 BLENDER is a medical device that received FDA 510(k) clearance on 2009-08-13. The listed applicant is Precision Medical, Inc.. The 510(k) number is K090781.

When did HELIO2 BLENDER receive FDA 510(k) clearance?

HELIO2 BLENDER received FDA 510(k) clearance on 2009-08-13, under 510(k) number K090781.

Who is the listed applicant for HELIO2 BLENDER?

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

What is the FDA product code for HELIO2 BLENDER?

The FDA product code for HELIO2 BLENDER is BZR.

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Other records listing Precision Medical, Inc. as applicant

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Related Devices (Code: BZR)

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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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