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FDA 510(k)

EMI MODEL FFF-IA

K-Number: K952164 · 1995-05-10

ApplicantNew York Heart Instruments, Inc.
Decision Date1995-05-10
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMI MODEL FFF-IA is the device name listed in this FDA 510(k) record. The listed applicant is New York Heart Instruments, Inc.. It received FDA 510(k) clearance on 1995-05-10 under 510(k) number K952164. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMI MODEL FFF-IA?

EMI MODEL FFF-IA is a medical device that received FDA 510(k) clearance on 1995-05-10. The listed applicant is New York Heart Instruments, Inc.. The 510(k) number is K952164.

When did EMI MODEL FFF-IA receive FDA 510(k) clearance?

EMI MODEL FFF-IA received FDA 510(k) clearance on 1995-05-10, under 510(k) number K952164.

Who is the listed applicant for EMI MODEL FFF-IA?

The FDA 510(k) record lists New York Heart Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMI MODEL FFF-IA?

The FDA product code for EMI MODEL FFF-IA is DQK.

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Related Devices (Code: DQK)

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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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