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FDA 510(k)

CARDIO SERV

K-Number: K951110 · 1995-09-15

ApplicantHellige GmbH
Decision Date1995-09-15
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO SERV is the device name listed in this FDA 510(k) record. The listed applicant is Hellige GmbH. It received FDA 510(k) clearance on 1995-09-15 under 510(k) number K951110. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO SERV?

CARDIO SERV is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is Hellige GmbH. The 510(k) number is K951110.

When did CARDIO SERV receive FDA 510(k) clearance?

CARDIO SERV received FDA 510(k) clearance on 1995-09-15, under 510(k) number K951110.

Who is the listed applicant for CARDIO SERV?

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 CARDIO SERV?

The FDA product code for CARDIO SERV is LDD.

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.

K950989CARDIOSMART

Related Devices (Code: LDD)

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.

K203231Switched Internal PaddlesPhilips North America, LLCK200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips CompanyK182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.K103651CARDIOMEDCardio Medical Products, Inc.K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab SpaK103334CARDIO MEDCardio Medical Products, Inc.

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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