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FDA 510(k)

SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)

K-Number: K971628 · 1997-10-10

ApplicantSomanetics Corp.
Decision Date1997-10-10
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) is the device name listed in this FDA 510(k) record. The listed applicant is Somanetics Corp.. It received FDA 510(k) clearance on 1997-10-10 under 510(k) number K971628. 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 SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)?

SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) is a medical device that received FDA 510(k) clearance on 1997-10-10. The listed applicant is Somanetics Corp.. The 510(k) number is K971628.

When did SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) receive FDA 510(k) clearance?

SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) received FDA 510(k) clearance on 1997-10-10, under 510(k) number K971628.

Who is the listed applicant for SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)?

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 SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)?

The FDA product code for SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) is DQA.

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Other records listing Somanetics Corp. as applicant

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.

K093422VITAL SYNC MODEL 5000 SERIESK091224OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-SK082327INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100CK080769INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100CK051274INVOS SYSTEMK040162CORRESTORE PATCH SYSTEM

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Related Devices (Code: DQA)

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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