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FDA 510(k)

ASC 4080 SYSTEM

K-Number: K843634 · 1984-11-08

ApplicantAtlantis Scientific Corp.
Decision Date1984-11-08
Product CodeIKE
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ASC 4080 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Atlantis Scientific Corp.. It received FDA 510(k) clearance on 1984-11-08 under 510(k) number K843634. The device is classified under product code IKE. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASC 4080 SYSTEM?

ASC 4080 SYSTEM is a medical device that received FDA 510(k) clearance on 1984-11-08. The listed applicant is Atlantis Scientific Corp.. The 510(k) number is K843634.

When did ASC 4080 SYSTEM receive FDA 510(k) clearance?

ASC 4080 SYSTEM received FDA 510(k) clearance on 1984-11-08, under 510(k) number K843634.

Who is the listed applicant for ASC 4080 SYSTEM?

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

What is the FDA product code for ASC 4080 SYSTEM?

The FDA product code for ASC 4080 SYSTEM is IKE.

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Related Devices (Code: IKE)

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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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