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FDA 510(k)

OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD

K-Number: K002036 · 2001-04-17

ApplicantOsi Medical, Inc.
Decision Date2001-04-17
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD is the device name listed in this FDA 510(k) record. The listed applicant is Osi Medical, Inc.. It received FDA 510(k) clearance on 2001-04-17 under 510(k) number K002036. 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 OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD?

OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD is a medical device that received FDA 510(k) clearance on 2001-04-17. The listed applicant is Osi Medical, Inc.. The 510(k) number is K002036.

When did OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD receive FDA 510(k) clearance?

OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD received FDA 510(k) clearance on 2001-04-17, under 510(k) number K002036.

Who is the listed applicant for OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD?

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

What is the FDA product code for OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD?

The FDA product code for OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD is DQA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Osi Medical, Inc. as applicant

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.

K012626OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDORK012533MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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