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FDA 510(k)

PALM ECG RECORDER, MODEL EP-201/202

K-Number: K061123 · 2007-06-29

ApplicantParama-Tech Company., Ltd.
Decision Date2007-06-29
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PALM ECG RECORDER, MODEL EP-201/202 is the device name listed in this FDA 510(k) record. The listed applicant is Parama-Tech Company., Ltd.. It received FDA 510(k) clearance on 2007-06-29 under 510(k) number K061123. 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 PALM ECG RECORDER, MODEL EP-201/202?

PALM ECG RECORDER, MODEL EP-201/202 is a medical device that received FDA 510(k) clearance on 2007-06-29. The listed applicant is Parama-Tech Company., Ltd.. The 510(k) number is K061123.

When did PALM ECG RECORDER, MODEL EP-201/202 receive FDA 510(k) clearance?

PALM ECG RECORDER, MODEL EP-201/202 received FDA 510(k) clearance on 2007-06-29, under 510(k) number K061123.

Who is the listed applicant for PALM ECG RECORDER, MODEL EP-201/202?

The FDA 510(k) record lists Parama-Tech Company., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PALM ECG RECORDER, MODEL EP-201/202?

The FDA product code for PALM ECG RECORDER, MODEL EP-201/202 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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