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FDA 510(k)

BIOSIGN CENTRAL STATION

K-Number: K071606 · 2007-08-31

ApplicantObs Medical
Decision Date2007-08-31
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOSIGN CENTRAL STATION is the device name listed in this FDA 510(k) record. The listed applicant is Obs Medical. It received FDA 510(k) clearance on 2007-08-31 under 510(k) number K071606. 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 CENTRAL STATION?

BIOSIGN CENTRAL STATION is a medical device that received FDA 510(k) clearance on 2007-08-31. The listed applicant is Obs Medical. The 510(k) number is K071606.

When did BIOSIGN CENTRAL STATION receive FDA 510(k) clearance?

BIOSIGN CENTRAL STATION received FDA 510(k) clearance on 2007-08-31, under 510(k) number K071606.

Who is the listed applicant for BIOSIGN CENTRAL STATION?

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

What is the FDA product code for BIOSIGN CENTRAL STATION?

The FDA product code for BIOSIGN CENTRAL STATION 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 Obs Medical 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.

K110953VISENSIA, VISENSIA WITH ALERTK081140VISENSIA

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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