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FDA 510(k)

EPOCH 2000 NEUROLOGICAL WORKSTATION

K-Number: K971819 · 1997-11-20

ApplicantAxon Systems, Inc.
Decision Date1997-11-20
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EPOCH 2000 NEUROLOGICAL WORKSTATION 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 1997-11-20 under 510(k) number K971819. 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 EPOCH 2000 NEUROLOGICAL WORKSTATION?

EPOCH 2000 NEUROLOGICAL WORKSTATION is a medical device that received FDA 510(k) clearance on 1997-11-20. The listed applicant is Axon Systems, Inc.. The 510(k) number is K971819.

When did EPOCH 2000 NEUROLOGICAL WORKSTATION receive FDA 510(k) clearance?

EPOCH 2000 NEUROLOGICAL WORKSTATION received FDA 510(k) clearance on 1997-11-20, under 510(k) number K971819.

Who is the listed applicant for EPOCH 2000 NEUROLOGICAL WORKSTATION?

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 EPOCH 2000 NEUROLOGICAL WORKSTATION?

The FDA product code for EPOCH 2000 NEUROLOGICAL WORKSTATION is GWF.

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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 INSTRUMENTSK062996DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBESK062198SUNSPOTS PRE-GELLED SURFACE ELECTRODESK061639ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMONK061113ORTHOMONK050798ECLIPSE NEUROLOGICAL WORKSTATION

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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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