FDA 510(k)

FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE

K-Number: K013273 · 2001-12-20

Decision Date2001-12-20

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 2001-12-20 under 510(k) number K013273. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE?

FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE is a medical device that received FDA 510(k) clearance on 2001-12-20. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K013273.

When did FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE receive FDA 510(k) clearance?

FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE received FDA 510(k) clearance on 2001-12-20, under 510(k) number K013273.

Who is the listed applicant for FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE?

The FDA 510(k) record lists Fukuda Denshi USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE?

The FDA product code for FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE is DQA.

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Related Devices (Code: DQA)

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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.