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FDA 510(k)

GUIDELINE SYSTEM

K-Number: K970943 · 1997-08-18

ApplicantAxon Instruments, Inc.
Decision Date1997-08-18
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GUIDELINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Axon Instruments, Inc.. It received FDA 510(k) clearance on 1997-08-18 under 510(k) number K970943. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUIDELINE SYSTEM?

GUIDELINE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-18. The listed applicant is Axon Instruments, Inc.. The 510(k) number is K970943.

When did GUIDELINE SYSTEM receive FDA 510(k) clearance?

GUIDELINE SYSTEM received FDA 510(k) clearance on 1997-08-18, under 510(k) number K970943.

Who is the listed applicant for GUIDELINE SYSTEM?

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

What is the FDA product code for GUIDELINE SYSTEM?

The FDA product code for GUIDELINE SYSTEM is GZL.

Related Clinical Trials

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Other records listing Axon Instruments, 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.

K990683AXON MP-1 MICROPOSITIONERK971318MM-1 MOVEMENT MONITOR

Related Devices (Code: GZL)

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.

K253970Wovyn Depth ElectrodeSensomedical Labs, Ltd.K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); DeptBeijing Sinovation Medical Technology Co., Ltd.K250601Neuro Omega System; NeuroSmart SystemAlpha Omega Engineering , Ltd.K223269Spencer Probe Depth ElectrodesAd-Tech Medical Instrument CorporationK223276Anchor Bolts as Accessories to Depth ElectrodesAd-Tech Medical Instrument CorporationK213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd.

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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