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FDA 510(k)

PROPAQ ECG TELEMETRY OPTION

K-Number: K934711 · 1994-09-01

ApplicantProtocol Systems, Inc.
Decision Date1994-09-01
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROPAQ ECG TELEMETRY OPTION 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 1994-09-01 under 510(k) number K934711. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPAQ ECG TELEMETRY OPTION?

PROPAQ ECG TELEMETRY OPTION is a medical device that received FDA 510(k) clearance on 1994-09-01. The listed applicant is Protocol Systems, Inc.. The 510(k) number is K934711.

When did PROPAQ ECG TELEMETRY OPTION receive FDA 510(k) clearance?

PROPAQ ECG TELEMETRY OPTION received FDA 510(k) clearance on 1994-09-01, under 510(k) number K934711.

Who is the listed applicant for PROPAQ ECG TELEMETRY OPTION?

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 PROPAQ ECG TELEMETRY OPTION?

The FDA product code for PROPAQ ECG TELEMETRY OPTION is DRG.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 MONITORK935846MODEL ACUITY CENTRAL STATIONK921497PROPAQ MONITORS, MODIFICATION

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Related Devices (Code: DRG)

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.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, 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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