FDA 510(k)

CYCLONE, MODEL MAICAM 180

K-Number: K060486 · 2006-03-23

Decision Date2006-03-23

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CYCLONE, MODEL MAICAM 180 is the device name listed in this FDA 510(k) record. The listed applicant is Spectrica. It received FDA 510(k) clearance on 2006-03-23 under 510(k) number K060486. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYCLONE, MODEL MAICAM 180?

CYCLONE, MODEL MAICAM 180 is a medical device that received FDA 510(k) clearance on 2006-03-23. The listed applicant is Spectrica. The 510(k) number is K060486.

When did CYCLONE, MODEL MAICAM 180 receive FDA 510(k) clearance?

CYCLONE, MODEL MAICAM 180 received FDA 510(k) clearance on 2006-03-23, under 510(k) number K060486.

Who is the listed applicant for CYCLONE, MODEL MAICAM 180?

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

What is the FDA product code for CYCLONE, MODEL MAICAM 180?

The FDA product code for CYCLONE, MODEL MAICAM 180 is KPS.

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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.