FDA 510(k)

DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070

K-Number: K012989 · 2002-03-20

Decision Date2002-03-20

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 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 2002-03-20 under 510(k) number K012989. 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 DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070?

DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 is a medical device that received FDA 510(k) clearance on 2002-03-20. The listed applicant is Dolphin Medical, Inc.. The 510(k) number is K012989.

When did DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 receive FDA 510(k) clearance?

DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 received FDA 510(k) clearance on 2002-03-20, under 510(k) number K012989.

Who is the listed applicant for DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070?

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 DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070?

The FDA product code for DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 is DQA.

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Other records listing Dolphin Medical, Inc. as applicant

K060524DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES K040380DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 K033876DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 K032947NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 K031465MODEL 2100 PULSE OXIMETER K030629DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER

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Related Devices (Code: DQA)

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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.