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FDA 510(k)

MODIFICATION TO ENCOMPASS

K-Number: K040896 · 2004-07-16

ApplicantHeartlab, Inc.
Decision Date2004-07-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ENCOMPASS is the device name listed in this FDA 510(k) record. The listed applicant is Heartlab, Inc.. It received FDA 510(k) clearance on 2004-07-16 under 510(k) number K040896. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ENCOMPASS?

MODIFICATION TO ENCOMPASS is a medical device that received FDA 510(k) clearance on 2004-07-16. The listed applicant is Heartlab, Inc.. The 510(k) number is K040896.

When did MODIFICATION TO ENCOMPASS receive FDA 510(k) clearance?

MODIFICATION TO ENCOMPASS received FDA 510(k) clearance on 2004-07-16, under 510(k) number K040896.

Who is the listed applicant for MODIFICATION TO ENCOMPASS?

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

What is the FDA product code for MODIFICATION TO ENCOMPASS?

The FDA product code for MODIFICATION TO ENCOMPASS is LLZ.

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Other records listing Heartlab, Inc. as applicant

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.

K050858ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEMK050228AGFA HEARTLAB CARDIOVASCULARK042042ULTRASOUND CAPTURE SYSTEMK954479DICOMVIEWK954860ECHONET

Related Devices (Code: LLZ)

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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