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FDA 510(k)

RESOLVE-HB

K-Number: K840011 · 1984-02-04

ApplicantIsolab, Inc.
Decision Date1984-02-04
Product CodeGKA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RESOLVE-HB is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K840011. The device is classified under product code GKA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESOLVE-HB?

RESOLVE-HB is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Isolab, Inc.. The 510(k) number is K840011.

When did RESOLVE-HB receive FDA 510(k) clearance?

RESOLVE-HB received FDA 510(k) clearance on 1984-02-04, under 510(k) number K840011.

Who is the listed applicant for RESOLVE-HB?

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

What is the FDA product code for RESOLVE-HB?

The FDA product code for RESOLVE-HB is GKA.

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Other records listing Isolab, Inc. as applicant

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Related Devices (Code: GKA)

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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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