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FDA 510(k)

SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER

K-Number: K042002 · 2004-10-20

ApplicantEla Medical, Inc.
Decision Date2004-10-20
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER is the device name listed in this FDA 510(k) record. The listed applicant is Ela Medical, Inc.. It received FDA 510(k) clearance on 2004-10-20 under 510(k) number K042002. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER?

SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER is a medical device that received FDA 510(k) clearance on 2004-10-20. The listed applicant is Ela Medical, Inc.. The 510(k) number is K042002.

When did SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER receive FDA 510(k) clearance?

SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER received FDA 510(k) clearance on 2004-10-20, under 510(k) number K042002.

Who is the listed applicant for SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER?

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

What is the FDA product code for SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER?

The FDA product code for SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER is DQK.

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Other records listing Ela Medical, Inc. as applicant

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Related Devices (Code: DQK)

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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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