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FDA 510(k)

ZOLL R SERIES

K-Number: K081574 · 2008-09-18

ApplicantZOLL Medical Corporation
Decision Date2008-09-18
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL R SERIES is the device name listed in this FDA 510(k) record. The listed applicant is ZOLL Medical Corporation. It received FDA 510(k) clearance on 2008-09-18 under 510(k) number K081574. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZOLL R SERIES?

ZOLL R SERIES is a medical device that received FDA 510(k) clearance on 2008-09-18. The listed applicant is ZOLL Medical Corporation. The 510(k) number is K081574.

When did ZOLL R SERIES receive FDA 510(k) clearance?

ZOLL R SERIES received FDA 510(k) clearance on 2008-09-18, under 510(k) number K081574.

Who is the listed applicant for ZOLL R SERIES?

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

What is the FDA product code for ZOLL R SERIES?

The FDA product code for ZOLL R SERIES is LDD.

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Related Devices (Code: LDD)

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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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