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FDA 510(k)

MODEL 508 PATIENT MONITOR

K-Number: K921309 · 1993-12-17

ApplicantCriticare Systems, Inc.
Decision Date1993-12-17
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 508 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 1993-12-17 under 510(k) number K921309. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 508 PATIENT MONITOR?

MODEL 508 PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 1993-12-17. The listed applicant is Criticare Systems, Inc.. The 510(k) number is K921309.

When did MODEL 508 PATIENT MONITOR receive FDA 510(k) clearance?

MODEL 508 PATIENT MONITOR received FDA 510(k) clearance on 1993-12-17, under 510(k) number K921309.

Who is the listed applicant for MODEL 508 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 MODEL 508 PATIENT MONITOR?

The FDA product code for MODEL 508 PATIENT MONITOR is BTY.

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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: BTY)

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.

K260242CPETWise PlatformMedibyt , Ltd.K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics CorporationK223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbHK231561Pulmonary Function Tester, Model: A9Guangzhou Homesun Medical Technology Co., Ltd.K222982Virtus Metabolic MonitorVirtus Technology ApsK221030Model 9100 PFT/DICOVitalograph Ireland, Ltd.

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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