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FDA 510(k)

OP-PNEU ELECTRONIC CO2

K-Number: K941438 · 1995-05-11

ApplicantWisap/U.S.A.
Decision Date1995-05-11
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OP-PNEU ELECTRONIC CO2 is the device name listed in this FDA 510(k) record. The listed applicant is Wisap/U.S.A.. It received FDA 510(k) clearance on 1995-05-11 under 510(k) number K941438. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OP-PNEU ELECTRONIC CO2?

OP-PNEU ELECTRONIC CO2 is a medical device that received FDA 510(k) clearance on 1995-05-11. The listed applicant is Wisap/U.S.A.. The 510(k) number is K941438.

When did OP-PNEU ELECTRONIC CO2 receive FDA 510(k) clearance?

OP-PNEU ELECTRONIC CO2 received FDA 510(k) clearance on 1995-05-11, under 510(k) number K941438.

Who is the listed applicant for OP-PNEU ELECTRONIC CO2?

The FDA 510(k) record lists Wisap/U.S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OP-PNEU ELECTRONIC CO2?

The FDA product code for OP-PNEU ELECTRONIC CO2 is HIF.

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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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