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FDA 510(k)

MORTARA ELI 10 ELECTROCARDIOGRAPH

K-Number: K070539 · 2007-03-15

ApplicantMortara Instrument, Inc.
Decision Date2007-03-15
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MORTARA ELI 10 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 2007-03-15 under 510(k) number K070539. 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 MORTARA ELI 10 ELECTROCARDIOGRAPH?

MORTARA ELI 10 ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 2007-03-15. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K070539.

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

MORTARA ELI 10 ELECTROCARDIOGRAPH received FDA 510(k) clearance on 2007-03-15, under 510(k) number K070539.

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

The FDA product code for MORTARA ELI 10 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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