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FDA 510(k)

CARDIAC VIEW, MODEL 2001

K-Number: K010802 · 2001-06-08

ApplicantMagna Lab, Inc.
Decision Date2001-06-08
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIAC VIEW, MODEL 2001 is the device name listed in this FDA 510(k) record. The listed applicant is Magna Lab, Inc.. It received FDA 510(k) clearance on 2001-06-08 under 510(k) number K010802. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC VIEW, MODEL 2001?

CARDIAC VIEW, MODEL 2001 is a medical device that received FDA 510(k) clearance on 2001-06-08. The listed applicant is Magna Lab, Inc.. The 510(k) number is K010802.

When did CARDIAC VIEW, MODEL 2001 receive FDA 510(k) clearance?

CARDIAC VIEW, MODEL 2001 received FDA 510(k) clearance on 2001-06-08, under 510(k) number K010802.

Who is the listed applicant for CARDIAC VIEW, MODEL 2001?

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

What is the FDA product code for CARDIAC VIEW, MODEL 2001?

The FDA product code for CARDIAC VIEW, MODEL 2001 is MOS.

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Other records listing Magna Lab, 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.

K020993ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB)K010513CARDIAC VIEW, MODEL 2001K940894MAGNA SL

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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