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FDA 510(k)

LIONHEART 3 MULTI-PARAMETER SIMULATOR

K-Number: K944257 · 1994-09-21

ApplicantBio-Tek Instruments, Inc.
Decision Date1994-09-21
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIONHEART 3 MULTI-PARAMETER SIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tek Instruments, Inc.. It received FDA 510(k) clearance on 1994-09-21 under 510(k) number K944257. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIONHEART 3 MULTI-PARAMETER SIMULATOR?

LIONHEART 3 MULTI-PARAMETER SIMULATOR is a medical device that received FDA 510(k) clearance on 1994-09-21. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K944257.

When did LIONHEART 3 MULTI-PARAMETER SIMULATOR receive FDA 510(k) clearance?

LIONHEART 3 MULTI-PARAMETER SIMULATOR received FDA 510(k) clearance on 1994-09-21, under 510(k) number K944257.

Who is the listed applicant for LIONHEART 3 MULTI-PARAMETER SIMULATOR?

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

What is the FDA product code for LIONHEART 3 MULTI-PARAMETER SIMULATOR?

The FDA product code for LIONHEART 3 MULTI-PARAMETER SIMULATOR is DRT.

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Related Devices (Code: DRT)

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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