FDA 510(k)

OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'

K-Number: K014218 · 2002-11-07

Decision Date2002-11-07

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' is the device name listed in this FDA 510(k) record. The listed applicant is Dolphin Medical, Inc.. It received FDA 510(k) clearance on 2002-11-07 under 510(k) number K014218. 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 DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'?

OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' is a medical device that received FDA 510(k) clearance on 2002-11-07. The listed applicant is Dolphin Medical, Inc.. The 510(k) number is K014218.

When did OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' receive FDA 510(k) clearance?

OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' received FDA 510(k) clearance on 2002-11-07, under 510(k) number K014218.

Who is the listed applicant for OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'?

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

What is the FDA product code for OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'?

The FDA product code for OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' is DQA.

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Other records listing Dolphin Medical, Inc. as applicant

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Related Devices (Code: DQA)

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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.