FDA 510(k)

OXY-CATH

K-Number: K881428 · 1988-06-10

ApplicantPulmonary Medical Devices, Inc.

Decision Date1988-06-10

Product CodeBSY

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

OXY-CATH is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonary Medical Devices, Inc.. It received FDA 510(k) clearance on 1988-06-10 under 510(k) number K881428. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXY-CATH?

OXY-CATH is a medical device that received FDA 510(k) clearance on 1988-06-10. The listed applicant is Pulmonary Medical Devices, Inc.. The 510(k) number is K881428.

When did OXY-CATH receive FDA 510(k) clearance?

OXY-CATH received FDA 510(k) clearance on 1988-06-10, under 510(k) number K881428.

Who is the listed applicant for OXY-CATH?

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

What is the FDA product code for OXY-CATH?

The FDA product code for OXY-CATH is BSY.

Related Devices (Code: BSY)

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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.