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FDA 510(k)

CARDIOSMART

K-Number: K950989 · 1996-05-13

ApplicantHellige GmbH
Decision Date1996-05-13
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSMART is the device name listed in this FDA 510(k) record. The listed applicant is Hellige GmbH. It received FDA 510(k) clearance on 1996-05-13 under 510(k) number K950989. 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 CARDIOSMART?

CARDIOSMART is a medical device that received FDA 510(k) clearance on 1996-05-13. The listed applicant is Hellige GmbH. The 510(k) number is K950989.

When did CARDIOSMART receive FDA 510(k) clearance?

CARDIOSMART received FDA 510(k) clearance on 1996-05-13, under 510(k) number K950989.

Who is the listed applicant for CARDIOSMART?

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

What is the FDA product code for CARDIOSMART?

The FDA product code for CARDIOSMART 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 Hellige GmbH 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.

K951110CARDIO SERV

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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