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FDA 510(k)

LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE

K-Number: K082256 · 2008-09-26

ApplicantIntegrated Medical Systems, Inc.
Decision Date2008-09-26
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Medical Systems, Inc.. It received FDA 510(k) clearance on 2008-09-26 under 510(k) number K082256. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE?

LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE is a medical device that received FDA 510(k) clearance on 2008-09-26. The listed applicant is Integrated Medical Systems, Inc.. The 510(k) number is K082256.

When did LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE receive FDA 510(k) clearance?

LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE received FDA 510(k) clearance on 2008-09-26, under 510(k) number K082256.

Who is the listed applicant for LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE?

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

What is the FDA product code for LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE?

The FDA product code for LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE is MWI.

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Other records listing Integrated Medical Systems, Inc. as applicant

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Related Devices (Code: MWI)

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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