Hutchinson Technology, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Hutchinson Technology, Inc. makes
Hutchinson Technology, Inc. manufactures near-infrared spectroscopy (NIRS) devices for monitoring tissue oxygenation and blood flow, including standalone spectrometers and handheld spot-check oximeters. Their products include the INSPECTRA Tissue Spectrometer System, the BIOSPECTROMETER-NB Oximeter, and the INSPECTRA STO₂ Tissue Oxygenation Monitor, designed for clinical and research use. Modifications to existing models are also part of their portfolio.
These devices are classified as Class II under FDA regulations and are authorised through the 510(k) pathway. The company is based in the United States, and its products are listed in the FDA’s 510(k) registry.
Catalogue
Spectra Tissue Spectrometer System (Inspectra) Ref K042020
Regimes: 510(k) Registry: 510(k)Inpectra STO2 Spot Check Ref K103613
Regimes: 510(k) Registry: 510(k)Biospectrometer-Nb Oximeter Iiii Ref K963903
Regimes: 510(k) Registry: 510(k)Inspectra STO2 Tissue Oxygenation Monitor Ref K061619
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Inspectra Tissue Spectrometer System, Model 325 Ref K053618
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hutchinson Technology, Inc. have in the registry?
The registry currently lists 8 devices for Hutchinson Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hutchinson Technology, Inc.'s devices?
Among its 8 most recently registered devices, Hutchinson Technology, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Hutchinson Technology, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Hutchinson Technology, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hutchinson Technology, Inc. in the registry?
The most recently registered devices listed for Hutchinson Technology, Inc. include SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), INPECTRA STO2 SPOT CHECK, BIOSPECTROMETER-NB OXIMETER IIII and INSPECTRA STO2 TISSUE OXYGENATION MONITOR.