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FDA 510(k)

ISIS MER SYSTEM/ELEKTA MER SYSTEM

K-Number: K042208 · 2005-03-18

ApplicantInomed Medizintechnik GmbH
Decision Date2005-03-18
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ISIS MER SYSTEM/ELEKTA MER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Inomed Medizintechnik GmbH. It received FDA 510(k) clearance on 2005-03-18 under 510(k) number K042208. 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 ISIS MER SYSTEM/ELEKTA MER SYSTEM?

ISIS MER SYSTEM/ELEKTA MER SYSTEM is a medical device that received FDA 510(k) clearance on 2005-03-18. The listed applicant is Inomed Medizintechnik GmbH. The 510(k) number is K042208.

When did ISIS MER SYSTEM/ELEKTA MER SYSTEM receive FDA 510(k) clearance?

ISIS MER SYSTEM/ELEKTA MER SYSTEM received FDA 510(k) clearance on 2005-03-18, under 510(k) number K042208.

Who is the listed applicant for ISIS MER SYSTEM/ELEKTA MER SYSTEM?

The FDA 510(k) record lists Inomed Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISIS MER SYSTEM/ELEKTA MER SYSTEM?

The FDA product code for ISIS MER SYSTEM/ELEKTA MER SYSTEM is GZL.

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Other records listing Inomed Medizintechnik GmbH 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.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressK242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressK223254C2 XploreK212164Mapping Suction ProbeK212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

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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

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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