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FDA 510(k)

REGIONAL OXIMETER SYSTEM, MODEL 7600

K-Number: K090807 · 2009-06-30

ApplicantNonin Medical, Inc.
Decision Date2009-06-30
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REGIONAL OXIMETER SYSTEM, MODEL 7600 is the device name listed in this FDA 510(k) record. The listed applicant is Nonin Medical, Inc.. It received FDA 510(k) clearance on 2009-06-30 under 510(k) number K090807. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGIONAL OXIMETER SYSTEM, MODEL 7600?

REGIONAL OXIMETER SYSTEM, MODEL 7600 is a medical device that received FDA 510(k) clearance on 2009-06-30. The listed applicant is Nonin Medical, Inc.. The 510(k) number is K090807.

When did REGIONAL OXIMETER SYSTEM, MODEL 7600 receive FDA 510(k) clearance?

REGIONAL OXIMETER SYSTEM, MODEL 7600 received FDA 510(k) clearance on 2009-06-30, under 510(k) number K090807.

Who is the listed applicant for REGIONAL OXIMETER SYSTEM, MODEL 7600?

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

What is the FDA product code for REGIONAL OXIMETER SYSTEM, MODEL 7600?

The FDA product code for REGIONAL OXIMETER SYSTEM, MODEL 7600 is MUD.

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Related Devices (Code: MUD)

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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.

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