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FDA 510(k)

SPECTRUM M2 MONITOR

K-Number: K062468 · 2006-09-13

ApplicantSpectrum Medical, Llp
Decision Date2006-09-13
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPECTRUM M2 MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical, Llp. It received FDA 510(k) clearance on 2006-09-13 under 510(k) number K062468. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM M2 MONITOR?

SPECTRUM M2 MONITOR is a medical device that received FDA 510(k) clearance on 2006-09-13. The listed applicant is Spectrum Medical, Llp. The 510(k) number is K062468.

When did SPECTRUM M2 MONITOR receive FDA 510(k) clearance?

SPECTRUM M2 MONITOR received FDA 510(k) clearance on 2006-09-13, under 510(k) number K062468.

Who is the listed applicant for SPECTRUM M2 MONITOR?

The FDA 510(k) record lists Spectrum Medical, Llp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRUM M2 MONITOR?

The FDA product code for SPECTRUM M2 MONITOR is DRY.

Related Clinical Trials

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.

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Other records listing Spectrum Medical, Llp 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.

K110957M4 MONITOR

Related Devices (Code: DRY)

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.

K234065CDI OneView Monitoring SystemTerumo Cardiovascular Systems CorporationK202154B-CaptaLivanova Deutschland, GmbHK202557Quantum Workstation 12 EliteSpectrum Medical , Ltd.K182110CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems CorporationK181923Quantum Workstation 12.1Spectrum Medical , Ltd.K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical , 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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