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FDA 510(k)

BIOSPECTROMETER-NB OXIMETER IIII

K-Number: K963903 · 1998-01-27

ApplicantHutchinson Technology, Inc.
Decision Date1998-01-27
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOSPECTROMETER-NB OXIMETER IIII 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 1998-01-27 under 510(k) number K963903. 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 BIOSPECTROMETER-NB OXIMETER IIII?

BIOSPECTROMETER-NB OXIMETER IIII is a medical device that received FDA 510(k) clearance on 1998-01-27. The listed applicant is Hutchinson Technology, Inc.. The 510(k) number is K963903.

When did BIOSPECTROMETER-NB OXIMETER IIII receive FDA 510(k) clearance?

BIOSPECTROMETER-NB OXIMETER IIII received FDA 510(k) clearance on 1998-01-27, under 510(k) number K963903.

Who is the listed applicant for BIOSPECTROMETER-NB OXIMETER IIII?

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 BIOSPECTROMETER-NB OXIMETER IIII?

The FDA product code for BIOSPECTROMETER-NB OXIMETER IIII 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 325K042020SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA)K023938MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, 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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