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FDA 510(k)

MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY

K-Number: K113215 · 2012-05-14

ApplicantNonin Medical, Inc.
Decision Date2012-05-14
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY 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 2012-05-14 under 510(k) number K113215. 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 MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY?

MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY is a medical device that received FDA 510(k) clearance on 2012-05-14. The listed applicant is Nonin Medical, Inc.. The 510(k) number is K113215.

When did MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY receive FDA 510(k) clearance?

MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY received FDA 510(k) clearance on 2012-05-14, under 510(k) number K113215.

Who is the listed applicant for MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY?

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 MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY?

The FDA product code for MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY is MUD.

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Related Devices (Code: MUD)

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.

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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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