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FDA 510(k)

KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE

K-Number: K971038 · 1997-09-24

ApplicantKontron Instruments , Ltd.
Decision Date1997-09-24
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Kontron Instruments , Ltd.. It received FDA 510(k) clearance on 1997-09-24 under 510(k) number K971038. 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 KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE?

KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE is a medical device that received FDA 510(k) clearance on 1997-09-24. The listed applicant is Kontron Instruments , Ltd.. The 510(k) number is K971038.

When did KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE receive FDA 510(k) clearance?

KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE received FDA 510(k) clearance on 1997-09-24, under 510(k) number K971038.

Who is the listed applicant for KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE?

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

What is the FDA product code for KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE?

The FDA product code for KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE is DPS.

Related Clinical Trials

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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

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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