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FDA 510(k)

HOLTER 24-HOUR ECG PLAYBACK, MODEL 150

K-Number: K884539 · 1989-01-17

ApplicantRmv Medical (Romavat, Inc.)
Decision Date1989-01-17
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLTER 24-HOUR ECG PLAYBACK, MODEL 150 is the device name listed in this FDA 510(k) record. The listed applicant is Rmv Medical (Romavat, Inc.). It received FDA 510(k) clearance on 1989-01-17 under 510(k) number K884539. 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 HOLTER 24-HOUR ECG PLAYBACK, MODEL 150?

HOLTER 24-HOUR ECG PLAYBACK, MODEL 150 is a medical device that received FDA 510(k) clearance on 1989-01-17. The listed applicant is Rmv Medical (Romavat, Inc.). The 510(k) number is K884539.

When did HOLTER 24-HOUR ECG PLAYBACK, MODEL 150 receive FDA 510(k) clearance?

HOLTER 24-HOUR ECG PLAYBACK, MODEL 150 received FDA 510(k) clearance on 1989-01-17, under 510(k) number K884539.

Who is the listed applicant for HOLTER 24-HOUR ECG PLAYBACK, MODEL 150?

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

What is the FDA product code for HOLTER 24-HOUR ECG PLAYBACK, MODEL 150?

The FDA product code for HOLTER 24-HOUR ECG PLAYBACK, MODEL 150 is DSI.

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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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