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FDA 510(k)

SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS

K-Number: K972199 · 1997-09-25

ApplicantMarquette Electronics, Inc.
Decision Date1997-09-25
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Marquette Electronics, Inc.. It received FDA 510(k) clearance on 1997-09-25 under 510(k) number K972199. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS?

SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS is a medical device that received FDA 510(k) clearance on 1997-09-25. The listed applicant is Marquette Electronics, Inc.. The 510(k) number is K972199.

When did SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS receive FDA 510(k) clearance?

SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS received FDA 510(k) clearance on 1997-09-25, under 510(k) number K972199.

Who is the listed applicant for SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS?

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

What is the FDA product code for SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS?

The FDA product code for SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS is DPS.

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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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