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FDA 510(k)

INSTACINE D-2000

K-Number: K983088 · 1998-09-22

ApplicantFidelity Medical, Inc.
Decision Date1998-09-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INSTACINE D-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Fidelity Medical, Inc.. It received FDA 510(k) clearance on 1998-09-22 under 510(k) number K983088. 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 INSTACINE D-2000?

INSTACINE D-2000 is a medical device that received FDA 510(k) clearance on 1998-09-22. The listed applicant is Fidelity Medical, Inc.. The 510(k) number is K983088.

When did INSTACINE D-2000 receive FDA 510(k) clearance?

INSTACINE D-2000 received FDA 510(k) clearance on 1998-09-22, under 510(k) number K983088.

Who is the listed applicant for INSTACINE D-2000?

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

What is the FDA product code for INSTACINE D-2000?

The FDA product code for INSTACINE D-2000 is LLZ.

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Other records listing Fidelity Medical, 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.

K942558INSTACINEK942504INSTASPOTK941917FLUOROPLUA CARDIAC AND/OR INSTAVIEWK903774LP-PLUSK872928LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPHK864614LP-3 ELECTROCARDIOGRAPH

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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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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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