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FDA 510(k)

PRAGER SHELL

K-Number: K082893 · 2008-12-05

ApplicantEsi, Inc.
Decision Date2008-12-05
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRAGER SHELL is the device name listed in this FDA 510(k) record. The listed applicant is Esi, Inc.. It received FDA 510(k) clearance on 2008-12-05 under 510(k) number K082893. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRAGER SHELL?

PRAGER SHELL is a medical device that received FDA 510(k) clearance on 2008-12-05. The listed applicant is Esi, Inc.. The 510(k) number is K082893.

When did PRAGER SHELL receive FDA 510(k) clearance?

PRAGER SHELL received FDA 510(k) clearance on 2008-12-05, under 510(k) number K082893.

Who is the listed applicant for PRAGER SHELL?

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

What is the FDA product code for PRAGER SHELL?

The FDA product code for PRAGER SHELL is ITX.

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Other records listing Esi, 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.

K080119CLEARSCAN

Related Devices (Code: ITX)

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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