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FDA 510(k)

VITAL SIGNS MONITOR

K-Number: K101602 · 2010-09-01

ApplicantCriticare Systems, Inc.
Decision Date2010-09-01
Product CodeMLD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITAL SIGNS MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Criticare Systems, Inc.. It received FDA 510(k) clearance on 2010-09-01 under 510(k) number K101602. The device is classified under product code MLD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITAL SIGNS MONITOR?

VITAL SIGNS MONITOR is a medical device that received FDA 510(k) clearance on 2010-09-01. The listed applicant is Criticare Systems, Inc.. The 510(k) number is K101602.

When did VITAL SIGNS MONITOR receive FDA 510(k) clearance?

VITAL SIGNS MONITOR received FDA 510(k) clearance on 2010-09-01, under 510(k) number K101602.

Who is the listed applicant for VITAL SIGNS MONITOR?

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

What is the FDA product code for VITAL SIGNS MONITOR?

The FDA product code for VITAL SIGNS MONITOR is MLD.

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 Criticare Systems, 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.

K091050506CN PATIENT MONITORK0425698600 VITAL SIGNS MONITORK030613VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100K022435507EL VITAL SIGNS MONITORK0120598100/8500 VITAL SIGNS MONITORK0010208100 VITAL SIGNS MONITOR

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Related Devices (Code: MLD)

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.

K080461STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0Philips Medical SystemsK022740DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWAREDatex-OhmedaK012837MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIESDatex-OhmedaK002105SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSISSiemens Medical Solutions USA, Inc.K992323DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIESDatex-Ohmeda, Inc.K982104ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500Medical Data Electronics

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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