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FDA 510(k)

DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES

K-Number: K062996 · 2007-01-12

ApplicantAxon Systems, Inc.
Decision Date2007-01-12
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES is the device name listed in this FDA 510(k) record. The listed applicant is Axon Systems, Inc.. It received FDA 510(k) clearance on 2007-01-12 under 510(k) number K062996. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES?

DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES is a medical device that received FDA 510(k) clearance on 2007-01-12. The listed applicant is Axon Systems, Inc.. The 510(k) number is K062996.

When did DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES receive FDA 510(k) clearance?

DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES received FDA 510(k) clearance on 2007-01-12, under 510(k) number K062996.

Who is the listed applicant for DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES?

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

What is the FDA product code for DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES?

The FDA product code for DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES is GXZ.

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Other records listing Axon Systems, 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.

K090838STIMULUS/DISSECTION INSTRUMENTSK062198SUNSPOTS PRE-GELLED SURFACE ELECTRODESK061639ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMONK061113ORTHOMONK050798ECLIPSE NEUROLOGICAL WORKSTATIONK050194AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES

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Related Devices (Code: GXZ)

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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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