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FDA 510(k)

ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10

K-Number: K102206 · 2011-02-18

ApplicantMortara Instrument, Inc.
Decision Date2011-02-18
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 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 2011-02-18 under 510(k) number K102206. 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 10 ELECTROCARDIOGRAPH MODEL ELI 10?

ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 is a medical device that received FDA 510(k) clearance on 2011-02-18. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K102206.

When did ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 receive FDA 510(k) clearance?

ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 received FDA 510(k) clearance on 2011-02-18, under 510(k) number K102206.

Who is the listed applicant for ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10?

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 10 ELECTROCARDIOGRAPH MODEL ELI 10?

The FDA product code for ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 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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