FDA 510(k)

FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE

K-Number: K945464 · 1995-02-01

Decision Date1995-02-01

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI MODE HG-302 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 1995-02-01 under 510(k) number K945464. 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 MODE HG-302 PULSE OXIMETER MODULE?

FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE is a medical device that received FDA 510(k) clearance on 1995-02-01. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K945464.

When did FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE receive FDA 510(k) clearance?

FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE received FDA 510(k) clearance on 1995-02-01, under 510(k) number K945464.

Who is the listed applicant for FUKUDA DENSHI MODE HG-302 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 MODE HG-302 PULSE OXIMETER MODULE?

The FDA product code for FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE is DQA.

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Related Devices (Code: DQA)

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin Systeme K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita Corporation K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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.