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FDA 510(k)

AGFA HEARTLAB CARDIOVASCULAR

K-Number: K050228 · 2005-02-18

ApplicantHeartlab, Inc.
Decision Date2005-02-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AGFA HEARTLAB CARDIOVASCULAR is the device name listed in this FDA 510(k) record. The listed applicant is Heartlab, Inc.. It received FDA 510(k) clearance on 2005-02-18 under 510(k) number K050228. 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 AGFA HEARTLAB CARDIOVASCULAR?

AGFA HEARTLAB CARDIOVASCULAR is a medical device that received FDA 510(k) clearance on 2005-02-18. The listed applicant is Heartlab, Inc.. The 510(k) number is K050228.

When did AGFA HEARTLAB CARDIOVASCULAR receive FDA 510(k) clearance?

AGFA HEARTLAB CARDIOVASCULAR received FDA 510(k) clearance on 2005-02-18, under 510(k) number K050228.

Who is the listed applicant for AGFA HEARTLAB CARDIOVASCULAR?

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 AGFA HEARTLAB CARDIOVASCULAR?

The FDA product code for AGFA HEARTLAB CARDIOVASCULAR 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 SYSTEMK042042ULTRASOUND CAPTURE SYSTEMK040896MODIFICATION TO ENCOMPASSK954479DICOMVIEWK954860ECHONET

Related Devices (Code: LLZ)

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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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