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FDA 510(k)

RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM

K-Number: K911835 · 1992-02-14

ApplicantGs Microsystems
Decision Date1992-02-14
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gs Microsystems. It received FDA 510(k) clearance on 1992-02-14 under 510(k) number K911835. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM?

RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM is a medical device that received FDA 510(k) clearance on 1992-02-14. The listed applicant is Gs Microsystems. The 510(k) number is K911835.

When did RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM receive FDA 510(k) clearance?

RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM received FDA 510(k) clearance on 1992-02-14, under 510(k) number K911835.

Who is the listed applicant for RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM?

The FDA 510(k) record lists Gs Microsystems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM?

The FDA product code for RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM is DSI.

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Related Devices (Code: DSI)

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

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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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