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FDA 510(k)

STIMULUS/DISSECTION INSTRUMENTS

K-Number: K090838 · 2009-07-20

ApplicantAxon Systems, Inc.
Decision Date2009-07-20
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

STIMULUS/DISSECTION INSTRUMENTS 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 2009-07-20 under 510(k) number K090838. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STIMULUS/DISSECTION INSTRUMENTS?

STIMULUS/DISSECTION INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2009-07-20. The listed applicant is Axon Systems, Inc.. The 510(k) number is K090838.

When did STIMULUS/DISSECTION INSTRUMENTS receive FDA 510(k) clearance?

STIMULUS/DISSECTION INSTRUMENTS received FDA 510(k) clearance on 2009-07-20, under 510(k) number K090838.

Who is the listed applicant for STIMULUS/DISSECTION INSTRUMENTS?

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 STIMULUS/DISSECTION INSTRUMENTS?

The FDA product code for STIMULUS/DISSECTION INSTRUMENTS is ETN.

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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.

K062996DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBESK062198SUNSPOTS 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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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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