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FDA 510(k)

PPM III

K-Number: K940712 · 1994-11-14

ApplicantO-Two Systems Intl., Inc.
Decision Date1994-11-14
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PPM III 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 1994-11-14 under 510(k) number K940712. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PPM III?

PPM III is a medical device that received FDA 510(k) clearance on 1994-11-14. The listed applicant is O-Two Systems Intl., Inc.. The 510(k) number is K940712.

When did PPM III receive FDA 510(k) clearance?

PPM III received FDA 510(k) clearance on 1994-11-14, under 510(k) number K940712.

Who is the listed applicant for PPM III?

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 PPM III?

The FDA product code for PPM III is CBP.

Other records listing O-Two Systems Intl., Inc. 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.

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