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FDA 510(k)

CAPS

K-Number: K932012 · 1993-11-03

ApplicantChemichl, Inc.
Decision Date1993-11-03
Product CodeELL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CAPS is the device name listed in this FDA 510(k) record. The listed applicant is Chemichl, Inc.. It received FDA 510(k) clearance on 1993-11-03 under 510(k) number K932012. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPS?

CAPS is a medical device that received FDA 510(k) clearance on 1993-11-03. The listed applicant is Chemichl, Inc.. The 510(k) number is K932012.

When did CAPS receive FDA 510(k) clearance?

CAPS received FDA 510(k) clearance on 1993-11-03, under 510(k) number K932012.

Who is the listed applicant for CAPS?

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

What is the FDA product code for CAPS?

The FDA product code for CAPS is ELL.

Related PubMed Literature

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.

PMID: 33844189New Visualization Models of Designation Pathway and Group Categorization of Device-Drug and Device-Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions.Therapeutic innovation & regulatory science ()

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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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