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FDA 510(k)

MODEL 2000 PULSE OXIMETER

K-Number: K982255 · 1998-10-22

ApplicantIvy Biomedical Systems, Inc.
Decision Date1998-10-22
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 2000 PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 1998-10-22 under 510(k) number K982255. 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 2000 PULSE OXIMETER?

MODEL 2000 PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 1998-10-22. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K982255.

When did MODEL 2000 PULSE OXIMETER receive FDA 510(k) clearance?

MODEL 2000 PULSE OXIMETER received FDA 510(k) clearance on 1998-10-22, under 510(k) number K982255.

Who is the listed applicant for MODEL 2000 PULSE OXIMETER?

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

What is the FDA product code for MODEL 2000 PULSE OXIMETER?

The FDA product code for MODEL 2000 PULSE OXIMETER is DQA.

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Related Devices (Code: DQA)

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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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