FDA 510(k)

SIRIUS 180, 180L, 230, 230L

K-Number: K961235 · 1997-01-08

Decision Date1997-01-08

Product CodeEFB

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

SIRIUS 180, 180L, 230, 230L is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Mega Societe Anonyme. It received FDA 510(k) clearance on 1997-01-08 under 510(k) number K961235. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIRIUS 180, 180L, 230, 230L?

SIRIUS 180, 180L, 230, 230L is a medical device that received FDA 510(k) clearance on 1997-01-08. The listed applicant is Micro-Mega Societe Anonyme. The 510(k) number is K961235.

When did SIRIUS 180, 180L, 230, 230L receive FDA 510(k) clearance?

SIRIUS 180, 180L, 230, 230L received FDA 510(k) clearance on 1997-01-08, under 510(k) number K961235.

Who is the listed applicant for SIRIUS 180, 180L, 230, 230L?

The FDA 510(k) record lists Micro-Mega Societe Anonyme as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIRIUS 180, 180L, 230, 230L?

The FDA product code for SIRIUS 180, 180L, 230, 230L is EFB.

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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.