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FDA 510(k)

INPECTRA STO2 SPOT CHECK

K-Number: K103613 · 2011-03-02

ApplicantHutchinson Technology, Inc.
Decision Date2011-03-02
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INPECTRA STO2 SPOT CHECK 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 2011-03-02 under 510(k) number K103613. 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 INPECTRA STO2 SPOT CHECK?

INPECTRA STO2 SPOT CHECK is a medical device that received FDA 510(k) clearance on 2011-03-02. The listed applicant is Hutchinson Technology, Inc.. The 510(k) number is K103613.

When did INPECTRA STO2 SPOT CHECK receive FDA 510(k) clearance?

INPECTRA STO2 SPOT CHECK received FDA 510(k) clearance on 2011-03-02, under 510(k) number K103613.

Who is the listed applicant for INPECTRA STO2 SPOT CHECK?

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 INPECTRA STO2 SPOT CHECK?

The FDA product code for INPECTRA STO2 SPOT CHECK 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.

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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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