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FDA 510(k)

OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S

K-Number: K091224 · 2009-07-09

ApplicantSomanetics Corp.
Decision Date2009-07-09
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S is the device name listed in this FDA 510(k) record. The listed applicant is Somanetics Corp.. It received FDA 510(k) clearance on 2009-07-09 under 510(k) number K091224. 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 OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S?

OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S is a medical device that received FDA 510(k) clearance on 2009-07-09. The listed applicant is Somanetics Corp.. The 510(k) number is K091224.

When did OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S receive FDA 510(k) clearance?

OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S received FDA 510(k) clearance on 2009-07-09, under 510(k) number K091224.

Who is the listed applicant for OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S?

The FDA 510(k) record lists Somanetics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S?

The FDA product code for OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S is MUD.

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Other records listing Somanetics Corp. as applicant

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K093422VITAL SYNC MODEL 5000 SERIESK082327INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100CK080769INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100CK051274INVOS SYSTEMK040162CORRESTORE PATCH SYSTEMK031586CORRESTORE PATCH SYSTEM

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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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