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FDA 510(k)

ARUBI FLATTER & ARUBI FLATTER-S

K-Number: K831206 · 1983-06-02

Decision Date1983-06-02
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ARUBI FLATTER & ARUBI FLATTER-S is the device name listed in this FDA 510(k) record. The listed applicant is Kc Export Management Co.. It received FDA 510(k) clearance on 1983-06-02 under 510(k) number K831206. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARUBI FLATTER & ARUBI FLATTER-S?

ARUBI FLATTER & ARUBI FLATTER-S is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is Kc Export Management Co.. The 510(k) number is K831206.

When did ARUBI FLATTER & ARUBI FLATTER-S receive FDA 510(k) clearance?

ARUBI FLATTER & ARUBI FLATTER-S received FDA 510(k) clearance on 1983-06-02, under 510(k) number K831206.

Who is the listed applicant for ARUBI FLATTER & ARUBI FLATTER-S?

The FDA 510(k) record lists Kc Export Management Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARUBI FLATTER & ARUBI FLATTER-S?

The FDA product code for ARUBI FLATTER & ARUBI FLATTER-S is ISA.

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: ISA)

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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