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FDA 510(k)

ULTRASOUND CAPTURE SYSTEM

K-Number: K042042 · 2004-09-21

ApplicantHeartlab, Inc.
Decision Date2004-09-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND CAPTURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Heartlab, Inc.. It received FDA 510(k) clearance on 2004-09-21 under 510(k) number K042042. 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 ULTRASOUND CAPTURE SYSTEM?

ULTRASOUND CAPTURE SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-21. The listed applicant is Heartlab, Inc.. The 510(k) number is K042042.

When did ULTRASOUND CAPTURE SYSTEM receive FDA 510(k) clearance?

ULTRASOUND CAPTURE SYSTEM received FDA 510(k) clearance on 2004-09-21, under 510(k) number K042042.

Who is the listed applicant for ULTRASOUND CAPTURE SYSTEM?

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 ULTRASOUND CAPTURE SYSTEM?

The FDA product code for ULTRASOUND CAPTURE SYSTEM is LLZ.

Related Clinical Trials

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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 CARDIOVASCULARK040896MODIFICATION TO ENCOMPASSK954479DICOMVIEWK954860ECHONET

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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