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FDA 510(k)

AUDIT V AX 135

K-Number: K833298 · 1983-12-01

ApplicantAxonics, Inc.
Decision Date1983-12-01
Product CodeGWK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AUDIT V AX 135 is the device name listed in this FDA 510(k) record. The listed applicant is Axonics, Inc.. It received FDA 510(k) clearance on 1983-12-01 under 510(k) number K833298. The device is classified under product code GWK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDIT V AX 135?

AUDIT V AX 135 is a medical device that received FDA 510(k) clearance on 1983-12-01. The listed applicant is Axonics, Inc.. The 510(k) number is K833298.

When did AUDIT V AX 135 receive FDA 510(k) clearance?

AUDIT V AX 135 received FDA 510(k) clearance on 1983-12-01, under 510(k) number K833298.

Who is the listed applicant for AUDIT V AX 135?

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

What is the FDA product code for AUDIT V AX 135?

The FDA product code for AUDIT V AX 135 is GWK.

Related Clinical Trials

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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Other records listing Axonics, 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.

K843712AUDIT TM VK831870ALLERGENETICS FLUORO-FAST READERK822335AUDITK823494TOTAL IGE-FAST TEST

Related Devices (Code: GWK)

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.

K060919ACTICALRespironics, Inc.K061870VITALSENSE XHRRespironics, Inc.K052489ACTIHEARTRespironics, Inc.K991045MINI-LOGGER SERIES 2000Mini-Mitter Co., Inc.K905594NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300Nihon Kohden America, Inc.K904328VISTA POLYSOMNOGRAPHY COMPUTER SYSTEMTelediagnostic Systems, Inc.

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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