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FDA 510(k)

SEDAT MYSHELL LITE

K-Number: K080472 · 2008-04-23

ApplicantSedat
Decision Date2008-04-23
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SEDAT MYSHELL LITE is the device name listed in this FDA 510(k) record. The listed applicant is Sedat. It received FDA 510(k) clearance on 2008-04-23 under 510(k) number K080472. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEDAT MYSHELL LITE?

SEDAT MYSHELL LITE is a medical device that received FDA 510(k) clearance on 2008-04-23. The listed applicant is Sedat. The 510(k) number is K080472.

When did SEDAT MYSHELL LITE receive FDA 510(k) clearance?

SEDAT MYSHELL LITE received FDA 510(k) clearance on 2008-04-23, under 510(k) number K080472.

Who is the listed applicant for SEDAT MYSHELL LITE?

The FDA 510(k) record lists Sedat as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEDAT MYSHELL LITE?

The FDA product code for SEDAT MYSHELL LITE is DTL.

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Other records listing Sedat 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.

K082755SEDAT FLAMINGOK060010NAUTIFLUX

Related Devices (Code: DTL)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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