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FDA 510(k)

ELI PC ELECTROCARDIOGRAPH

K-Number: K093339 · 2010-02-19

ApplicantMortara Instrument, Inc.
Decision Date2010-02-19
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELI PC ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2010-02-19 under 510(k) number K093339. 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 ELI PC ELECTROCARDIOGRAPH?

ELI PC ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 2010-02-19. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K093339.

When did ELI PC ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

ELI PC ELECTROCARDIOGRAPH received FDA 510(k) clearance on 2010-02-19, under 510(k) number K093339.

Who is the listed applicant for ELI PC ELECTROCARDIOGRAPH?

The FDA 510(k) record lists Mortara Instrument, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELI PC ELECTROCARDIOGRAPH?

The FDA product code for ELI PC ELECTROCARDIOGRAPH is DPS.

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Other records listing Mortara Instrument, Inc. as applicant

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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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