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FDA 510(k)

FLYNNR GENESIS II A/C, A/O AND IDLH

K-Number: K932170 · 1993-10-25

ApplicantO-Two Systems Intl., Inc.
Decision Date1993-10-25
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLYNNR GENESIS II A/C, A/O AND IDLH is the device name listed in this FDA 510(k) record. The listed applicant is O-Two Systems Intl., Inc.. It received FDA 510(k) clearance on 1993-10-25 under 510(k) number K932170. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLYNNR GENESIS II A/C, A/O AND IDLH?

FLYNNR GENESIS II A/C, A/O AND IDLH is a medical device that received FDA 510(k) clearance on 1993-10-25. The listed applicant is O-Two Systems Intl., Inc.. The 510(k) number is K932170.

When did FLYNNR GENESIS II A/C, A/O AND IDLH receive FDA 510(k) clearance?

FLYNNR GENESIS II A/C, A/O AND IDLH received FDA 510(k) clearance on 1993-10-25, under 510(k) number K932170.

Who is the listed applicant for FLYNNR GENESIS II A/C, A/O AND IDLH?

The FDA 510(k) record lists O-Two Systems Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLYNNR GENESIS II A/C, A/O AND IDLH?

The FDA product code for FLYNNR GENESIS II A/C, A/O AND IDLH is BTL.

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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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