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FDA 510(k)

AUDIT TM V

K-Number: K843712 · 1985-04-05

ApplicantAxonics, Inc.
Decision Date1985-04-05
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AUDIT TM V is the device name listed in this FDA 510(k) record. The listed applicant is Axonics, Inc.. It received FDA 510(k) clearance on 1985-04-05 under 510(k) number K843712. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDIT TM V?

AUDIT TM V is a medical device that received FDA 510(k) clearance on 1985-04-05. The listed applicant is Axonics, Inc.. The 510(k) number is K843712.

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

AUDIT TM V received FDA 510(k) clearance on 1985-04-05, under 510(k) number K843712.

Who is the listed applicant for AUDIT TM V?

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 TM V?

The FDA product code for AUDIT TM V is GWF.

Related Clinical Trials

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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.

K833298AUDIT V AX 135K831870ALLERGENETICS FLUORO-FAST READERK822335AUDITK823494TOTAL IGE-FAST TEST

Related Devices (Code: GWF)

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.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx Neuroscience

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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