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FDA 510(k)

ICASE

K-Number: K021248 · 2002-09-24

ApplicantIkeeps, Inc.
Decision Date2002-09-24
Product CodeLRX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ICASE is the device name listed in this FDA 510(k) record. The listed applicant is Ikeeps, Inc.. It received FDA 510(k) clearance on 2002-09-24 under 510(k) number K021248. The device is classified under product code LRX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICASE?

ICASE is a medical device that received FDA 510(k) clearance on 2002-09-24. The listed applicant is Ikeeps, Inc.. The 510(k) number is K021248.

When did ICASE receive FDA 510(k) clearance?

ICASE received FDA 510(k) clearance on 2002-09-24, under 510(k) number K021248.

Who is the listed applicant for ICASE?

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

What is the FDA product code for ICASE?

The FDA product code for ICASE is LRX.

Related Clinical Trials

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.

Related Devices (Code: LRX)

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.

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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