FDA 510(k)

DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100

K-Number: K021959 · 2002-07-11

Decision Date2002-07-11

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 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 2002-07-11 under 510(k) number K021959. 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 MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100?

DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 is a medical device that received FDA 510(k) clearance on 2002-07-11. The listed applicant is Dolphin Medical, Inc.. The 510(k) number is K021959.

When did DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 receive FDA 510(k) clearance?

DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 received FDA 510(k) clearance on 2002-07-11, under 510(k) number K021959.

Who is the listed applicant for DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100?

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 MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100?

The FDA product code for DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 is DQA.

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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.