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FDA 510(k)

MORTARA ELI 350 ELECTROCARDIOGRAPH

K-Number: K082946 · 2008-12-29

ApplicantMortara Instrument, Inc.
Decision Date2008-12-29
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MORTARA ELI 350 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 2008-12-29 under 510(k) number K082946. 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 350 ELECTROCARDIOGRAPH?

MORTARA ELI 350 ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 2008-12-29. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K082946.

When did MORTARA ELI 350 ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

MORTARA ELI 350 ELECTROCARDIOGRAPH received FDA 510(k) clearance on 2008-12-29, under 510(k) number K082946.

Who is the listed applicant for MORTARA ELI 350 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 350 ELECTROCARDIOGRAPH?

The FDA product code for MORTARA ELI 350 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.

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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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