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FDA 510(k)

8600 VITAL SIGNS MONITOR

K-Number: K042569 · 2004-09-29

ApplicantCriticare Systems, Inc.
Decision Date2004-09-29
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

8600 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 2004-09-29 under 510(k) number K042569. 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 8600 VITAL SIGNS MONITOR?

8600 VITAL SIGNS MONITOR is a medical device that received FDA 510(k) clearance on 2004-09-29. The listed applicant is Criticare Systems, Inc.. The 510(k) number is K042569.

When did 8600 VITAL SIGNS MONITOR receive FDA 510(k) clearance?

8600 VITAL SIGNS MONITOR received FDA 510(k) clearance on 2004-09-29, under 510(k) number K042569.

Who is the listed applicant for 8600 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 8600 VITAL SIGNS MONITOR?

The FDA product code for 8600 VITAL SIGNS MONITOR 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 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.

K101602VITAL SIGNS MONITORK091050506CN PATIENT MONITORK030613VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100K022435507EL VITAL SIGNS MONITORK0120598100/8500 VITAL SIGNS MONITORK0010208100 VITAL SIGNS MONITOR

View all 22 devices →

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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