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FDA 510(k)

CARDIOVISION SOFTWARE, MODEL S-CV5-96

K-Number: K981807 · 1998-08-19

ApplicantShl Telemedicine International , Ltd.
Decision Date1998-08-19
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOVISION SOFTWARE, MODEL S-CV5-96 is the device name listed in this FDA 510(k) record. The listed applicant is Shl Telemedicine International , Ltd.. It received FDA 510(k) clearance on 1998-08-19 under 510(k) number K981807. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVISION SOFTWARE, MODEL S-CV5-96?

CARDIOVISION SOFTWARE, MODEL S-CV5-96 is a medical device that received FDA 510(k) clearance on 1998-08-19. The listed applicant is Shl Telemedicine International , Ltd.. The 510(k) number is K981807.

When did CARDIOVISION SOFTWARE, MODEL S-CV5-96 receive FDA 510(k) clearance?

CARDIOVISION SOFTWARE, MODEL S-CV5-96 received FDA 510(k) clearance on 1998-08-19, under 510(k) number K981807.

Who is the listed applicant for CARDIOVISION SOFTWARE, MODEL S-CV5-96?

The FDA 510(k) record lists Shl Telemedicine International , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOVISION SOFTWARE, MODEL S-CV5-96?

The FDA product code for CARDIOVISION SOFTWARE, MODEL S-CV5-96 is DPS.

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.

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Other records listing Shl Telemedicine International , Ltd. 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.

K113514SMARTHEARTK080047CARDIOSEN'CK063609RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTERK003392CARDIO MONITOR CENTER VISION; MODEL S-CV7-00

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

Official Source

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