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FDA 510(k)

COMBI

K-Number: K840624 · 1984-02-27

ApplicantBesam, Inc.
Decision Date1984-02-27
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COMBI is the device name listed in this FDA 510(k) record. The listed applicant is Besam, Inc.. It received FDA 510(k) clearance on 1984-02-27 under 510(k) number K840624. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBI?

COMBI is a medical device that received FDA 510(k) clearance on 1984-02-27. The listed applicant is Besam, Inc.. The 510(k) number is K840624.

When did COMBI receive FDA 510(k) clearance?

COMBI received FDA 510(k) clearance on 1984-02-27, under 510(k) number K840624.

Who is the listed applicant for COMBI?

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

What is the FDA product code for COMBI?

The FDA product code for COMBI is ITI.

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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: 39736921US regulatory compliance for medical combination products: an overview.Frontiers in medical technology ()PMID: 39669903Navigating regulatory and policy challenges for AI enabled combination devices.Frontiers in medical technology ()PMID: 35872298Medicinal products meet medical devices: Classification and nomenclature issues arising from their combined use.Drug discovery today ()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 ()

Related Devices (Code: ITI)

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Official Source

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