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FDA 510(k)

SCHOLAR PATIENT MONITOR

K-Number: K944860 · 1995-06-20

ApplicantCriticare Systems, Inc.
Decision Date1995-06-20
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCHOLAR PATIENT 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 1995-06-20 under 510(k) number K944860. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCHOLAR PATIENT MONITOR?

SCHOLAR PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 1995-06-20. The listed applicant is Criticare Systems, Inc.. The 510(k) number is K944860.

When did SCHOLAR PATIENT MONITOR receive FDA 510(k) clearance?

SCHOLAR PATIENT MONITOR received FDA 510(k) clearance on 1995-06-20, under 510(k) number K944860.

Who is the listed applicant for SCHOLAR PATIENT 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 SCHOLAR PATIENT MONITOR?

The FDA product code for SCHOLAR PATIENT MONITOR is MHX.

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

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Related Devices (Code: MHX)

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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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