FDA 510(k)

MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A

K-Number: K071058 · 2007-06-29

Decision Date2007-06-29

Product CodeDRG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 2007-06-29 under 510(k) number K071058. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A?

MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A is a medical device that received FDA 510(k) clearance on 2007-06-29. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K071058.

When did MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A receive FDA 510(k) clearance?

MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A received FDA 510(k) clearance on 2007-06-29, under 510(k) number K071058.

Who is the listed applicant for MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A?

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

What is the FDA product code for MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A?

The FDA product code for MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A is DRG.

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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.