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FDA 510(k)

ACUITY CENTRAL STATION

K-Number: K972121 · 1997-11-07

ApplicantProtocol Systems, Inc.
Decision Date1997-11-07
Product CodeMLD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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 1997-11-07 under 510(k) number K972121. 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 ACUITY CENTRAL STATION?

ACUITY CENTRAL STATION is a medical device that received FDA 510(k) clearance on 1997-11-07. The listed applicant is Protocol Systems, Inc.. The 510(k) number is K972121.

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

ACUITY CENTRAL STATION received FDA 510(k) clearance on 1997-11-07, under 510(k) number K972121.

Who is the listed applicant for 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 ACUITY CENTRAL STATION?

The FDA product code for ACUITY CENTRAL STATION is MLD.

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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 404K951246PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONSK945071PROPAQ 200 MONITORK935846MODEL ACUITY CENTRAL STATIONK934711PROPAQ ECG TELEMETRY OPTIONK921497PROPAQ MONITORS, MODIFICATION

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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.

K101602VITAL SIGNS MONITORCriticare Systems, Inc.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.

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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