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FDA 510(k)

CARDIO-PAGER SYSTEM

K-Number: K973527 · 1998-03-31

ApplicantData Critical Corp.
Decision Date1998-03-31
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO-PAGER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Data Critical Corp.. It received FDA 510(k) clearance on 1998-03-31 under 510(k) number K973527. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO-PAGER SYSTEM?

CARDIO-PAGER SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-31. The listed applicant is Data Critical Corp.. The 510(k) number is K973527.

When did CARDIO-PAGER SYSTEM receive FDA 510(k) clearance?

CARDIO-PAGER SYSTEM received FDA 510(k) clearance on 1998-03-31, under 510(k) number K973527.

Who is the listed applicant for CARDIO-PAGER SYSTEM?

The FDA 510(k) record lists Data Critical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIO-PAGER SYSTEM?

The FDA product code for CARDIO-PAGER SYSTEM is MSX.

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Other records listing Data Critical Corp. 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.

K013156MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEMK012005MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEMK011999MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEMK010912ALARMVIEW WIRELESS DATA NETWORK SYSTEMK003998FLEXVIEW CLINICAL MONITORING SYSTEMK992848ALARMVIEW SYSTEM

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Related Devices (Code: MSX)

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.

K261287Digistat CareAscom Ums Srl UnipersonaleK260211Dashboard (P007000)Hill-Rom, Inc.K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbHK243270TigerConnect Alarm ManagementTigerconnectK242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., 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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