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FDA 510(k)

INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650

K-Number: K100915 · 2010-04-30

ApplicantHutchinson Technology, Inc.
Decision Date2010-04-30
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 is the device name listed in this FDA 510(k) record. The listed applicant is Hutchinson Technology, Inc.. It received FDA 510(k) clearance on 2010-04-30 under 510(k) number K100915. 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 INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650?

INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 is a medical device that received FDA 510(k) clearance on 2010-04-30. The listed applicant is Hutchinson Technology, Inc.. The 510(k) number is K100915.

When did INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 receive FDA 510(k) clearance?

INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 received FDA 510(k) clearance on 2010-04-30, under 510(k) number K100915.

Who is the listed applicant for INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650?

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

What is the FDA product code for INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650?

The FDA product code for INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 is MUD.

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Other records listing Hutchinson Technology, Inc. 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.

K103613INPECTRA STO2 SPOT CHECKK061619INSPECTRA STO2 TISSUE OXYGENATION MONITORK053618INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325K042020SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA)K023938MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325K012759INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325

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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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