FDA 510(k)

SIRIUS 10, 10L, 40, 40L

K-Number: K961275 · 1997-01-17

Decision Date1997-01-17

Product CodeEFB

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

SIRIUS 10, 10L, 40, 40L 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 1997-01-17 under 510(k) number K961275. 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 10, 10L, 40, 40L?

SIRIUS 10, 10L, 40, 40L is a medical device that received FDA 510(k) clearance on 1997-01-17. The listed applicant is Micro-Mega Societe Anonyme. The 510(k) number is K961275.

When did SIRIUS 10, 10L, 40, 40L receive FDA 510(k) clearance?

SIRIUS 10, 10L, 40, 40L received FDA 510(k) clearance on 1997-01-17, under 510(k) number K961275.

Who is the listed applicant for SIRIUS 10, 10L, 40, 40L?

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 10, 10L, 40, 40L?

The FDA product code for SIRIUS 10, 10L, 40, 40L is EFB.

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Other records listing Micro-Mega Societe Anonyme as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.