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FDA 510(k)

SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA)

K-Number: K042020 · 2004-09-15

ApplicantHutchinson Technology, Inc.
Decision Date2004-09-15
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) 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 2004-09-15 under 510(k) number K042020. 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 SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA)?

SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) is a medical device that received FDA 510(k) clearance on 2004-09-15. The listed applicant is Hutchinson Technology, Inc.. The 510(k) number is K042020.

When did SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) receive FDA 510(k) clearance?

SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) received FDA 510(k) clearance on 2004-09-15, under 510(k) number K042020.

Who is the listed applicant for SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA)?

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 SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA)?

The FDA product code for SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) 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 CHECKK100915INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650K061619INSPECTRA STO2 TISSUE OXYGENATION MONITORK053618INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325K023938MODIFICATION 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.

K254129Spectrum-2Neko Health ABK243324Masimo O3 Regional OximeterMasimo CorporationK250519Lap.Ox™ Laparoscopic Tissue OximeterViOptix, Inc.K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards LifesciencesK241393ODI-TechOdi Medical ASK240601SnapshotNIR model KD205Kent Imaging, Inc.

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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