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FDA 510(k)

CARDIO MONITOR CENTER VISION; MODEL S-CV7-00

K-Number: K003392 · 2001-01-25

ApplicantShl Telemedicine International , Ltd.
Decision Date2001-01-25
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 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 2001-01-25 under 510(k) number K003392. 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 CARDIO MONITOR CENTER VISION; MODEL S-CV7-00?

CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 is a medical device that received FDA 510(k) clearance on 2001-01-25. The listed applicant is Shl Telemedicine International , Ltd.. The 510(k) number is K003392.

When did CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 receive FDA 510(k) clearance?

CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 received FDA 510(k) clearance on 2001-01-25, under 510(k) number K003392.

Who is the listed applicant for CARDIO MONITOR CENTER VISION; MODEL S-CV7-00?

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 CARDIO MONITOR CENTER VISION; MODEL S-CV7-00?

The FDA product code for CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 is DPS.

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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 TRANSMITTERK981807CARDIOVISION SOFTWARE, MODEL S-CV5-96

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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