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FDA 510(k)

AL-800PA PULSE OXIMETER MODULE

K-Number: K884536 · 1989-02-06

ApplicantNihon Kohden America, Inc.
Decision Date1989-02-06
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AL-800PA PULSE OXIMETER MODULE 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 1989-02-06 under 510(k) number K884536. 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 AL-800PA PULSE OXIMETER MODULE?

AL-800PA PULSE OXIMETER MODULE is a medical device that received FDA 510(k) clearance on 1989-02-06. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K884536.

When did AL-800PA PULSE OXIMETER MODULE receive FDA 510(k) clearance?

AL-800PA PULSE OXIMETER MODULE received FDA 510(k) clearance on 1989-02-06, under 510(k) number K884536.

Who is the listed applicant for AL-800PA PULSE OXIMETER MODULE?

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 AL-800PA PULSE OXIMETER MODULE?

The FDA product code for AL-800PA PULSE OXIMETER MODULE is DQA.

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Other records listing Nihon Kohden America, Inc. as applicant

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Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse 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 SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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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