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FDA 510(k)

MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500

K-Number: K001930 · 2000-07-20

ApplicantNonin Medical, Inc.
Decision Date2000-07-20
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 is the device name listed in this FDA 510(k) record. The listed applicant is Nonin Medical, Inc.. It received FDA 510(k) clearance on 2000-07-20 under 510(k) number K001930. 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 MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500?

MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 is a medical device that received FDA 510(k) clearance on 2000-07-20. The listed applicant is Nonin Medical, Inc.. The 510(k) number is K001930.

When did MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 receive FDA 510(k) clearance?

MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 received FDA 510(k) clearance on 2000-07-20, under 510(k) number K001930.

Who is the listed applicant for MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500?

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

What is the FDA product code for MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500?

The FDA product code for MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 is DQA.

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Other records listing Nonin Medical, 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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