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FDA 510(k)

BALL RECORDING ELECTRODE/STIMULATION PROBE

K-Number: K030517 · 2003-08-01

ApplicantViasys Healthcare, Inc.
Decision Date2003-08-01
Product CodeGZK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BALL RECORDING ELECTRODE/STIMULATION PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Viasys Healthcare, Inc.. It received FDA 510(k) clearance on 2003-08-01 under 510(k) number K030517. The device is classified under product code GZK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BALL RECORDING ELECTRODE/STIMULATION PROBE?

BALL RECORDING ELECTRODE/STIMULATION PROBE is a medical device that received FDA 510(k) clearance on 2003-08-01. The listed applicant is Viasys Healthcare, Inc.. The 510(k) number is K030517.

When did BALL RECORDING ELECTRODE/STIMULATION PROBE receive FDA 510(k) clearance?

BALL RECORDING ELECTRODE/STIMULATION PROBE received FDA 510(k) clearance on 2003-08-01, under 510(k) number K030517.

Who is the listed applicant for BALL RECORDING ELECTRODE/STIMULATION PROBE?

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

What is the FDA product code for BALL RECORDING ELECTRODE/STIMULATION PROBE?

The FDA product code for BALL RECORDING ELECTRODE/STIMULATION PROBE is GZK.

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Other records listing Viasys Healthcare, 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.

K060421SONARA; SONARA/TEKK031713AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS

Related Devices (Code: GZK)

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.

K830325TIGER PULSEBertone & Assoc.

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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