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FDA 510(k)

CORSAIRE

K-Number: K982750 · 1999-02-01

ApplicantOptiway, Inc.
Decision Date1999-02-01
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CORSAIRE is the device name listed in this FDA 510(k) record. The listed applicant is Optiway, Inc.. It received FDA 510(k) clearance on 1999-02-01 under 510(k) number K982750. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORSAIRE?

CORSAIRE is a medical device that received FDA 510(k) clearance on 1999-02-01. The listed applicant is Optiway, Inc.. The 510(k) number is K982750.

When did CORSAIRE receive FDA 510(k) clearance?

CORSAIRE received FDA 510(k) clearance on 1999-02-01, under 510(k) number K982750.

Who is the listed applicant for CORSAIRE?

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

What is the FDA product code for CORSAIRE?

The FDA product code for CORSAIRE is ITI.

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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.

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