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FDA 510(k)

CEROS 80 (HA)

K-Number: K900136 · 1991-01-29

ApplicantMathys Corp.
Decision Date1991-01-29
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CEROS 80 (HA) is the device name listed in this FDA 510(k) record. The listed applicant is Mathys Corp.. It received FDA 510(k) clearance on 1991-01-29 under 510(k) number K900136. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEROS 80 (HA)?

CEROS 80 (HA) is a medical device that received FDA 510(k) clearance on 1991-01-29. The listed applicant is Mathys Corp.. The 510(k) number is K900136.

When did CEROS 80 (HA) receive FDA 510(k) clearance?

CEROS 80 (HA) received FDA 510(k) clearance on 1991-01-29, under 510(k) number K900136.

Who is the listed applicant for CEROS 80 (HA)?

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

What is the FDA product code for CEROS 80 (HA)?

The FDA product code for CEROS 80 (HA) is LYC.

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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.

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