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FDA 510(k)

MODEL ACUITY CENTRAL STATION

K-Number: K935846 · 1994-12-05

ApplicantProtocol Systems, Inc.
Decision Date1994-12-05
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL ACUITY CENTRAL STATION is the device name listed in this FDA 510(k) record. The listed applicant is Protocol Systems, Inc.. It received FDA 510(k) clearance on 1994-12-05 under 510(k) number K935846. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL ACUITY CENTRAL STATION?

MODEL ACUITY CENTRAL STATION is a medical device that received FDA 510(k) clearance on 1994-12-05. The listed applicant is Protocol Systems, Inc.. The 510(k) number is K935846.

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

MODEL ACUITY CENTRAL STATION received FDA 510(k) clearance on 1994-12-05, under 510(k) number K935846.

Who is the listed applicant for MODEL ACUITY CENTRAL STATION?

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

What is the FDA product code for MODEL ACUITY CENTRAL STATION?

The FDA product code for MODEL ACUITY CENTRAL STATION is DSI.

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Other records listing Protocol 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.

K002725MICROPAQ, MODELS 402 AND 404K972121ACUITY CENTRAL STATIONK951246PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONSK945071PROPAQ 200 MONITORK934711PROPAQ ECG TELEMETRY OPTIONK921497PROPAQ MONITORS, MODIFICATION

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Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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