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FDA 510(k)

BIOSIGN

K-Number: K053112 · 2006-01-31

ApplicantOxford Biosignals Limited
Decision Date2006-01-31
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOSIGN is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Biosignals Limited. It received FDA 510(k) clearance on 2006-01-31 under 510(k) number K053112. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSIGN?

BIOSIGN is a medical device that received FDA 510(k) clearance on 2006-01-31. The listed applicant is Oxford Biosignals Limited. The 510(k) number is K053112.

When did BIOSIGN receive FDA 510(k) clearance?

BIOSIGN received FDA 510(k) clearance on 2006-01-31, under 510(k) number K053112.

Who is the listed applicant for BIOSIGN?

The FDA 510(k) record lists Oxford Biosignals Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSIGN?

The FDA product code for BIOSIGN is MWI.

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 Oxford Biosignals Limited 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.

K042309BIOSOMNIA-V3K021485BIOSOMNIAK002622BIOSLEEP

Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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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