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FDA 510(k)

HEARLAB ACA

K-Number: K123701 · 2013-04-05

ApplicantFrye Electronics, Inc.
Decision Date2013-04-05
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HEARLAB ACA is the device name listed in this FDA 510(k) record. The listed applicant is Frye Electronics, Inc.. It received FDA 510(k) clearance on 2013-04-05 under 510(k) number K123701. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARLAB ACA?

HEARLAB ACA is a medical device that received FDA 510(k) clearance on 2013-04-05. The listed applicant is Frye Electronics, Inc.. The 510(k) number is K123701.

When did HEARLAB ACA receive FDA 510(k) clearance?

HEARLAB ACA received FDA 510(k) clearance on 2013-04-05, under 510(k) number K123701.

Who is the listed applicant for HEARLAB ACA?

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

What is the FDA product code for HEARLAB ACA?

The FDA product code for HEARLAB ACA is GWJ.

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Other records listing Frye Electronics, 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.

K093006FONIX ,MODEL 8000K022510FONIX, MODEL 7000K980377FONIX FP35 HEARING AID ANALYZERK935400FONIX 3500 HEARING AID ANALYZERK913221TYPE FA10 AUDIOMETERK895383TYPE FP40 DIGITAL HEARING AID ANALYZER

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Related Devices (Code: GWJ)

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.

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing Systems

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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