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FDA 510(k)

VIANOX DELIVERY SYSTEM, MODEL I

K-Number: K023014 · 2003-08-14

ApplicantPulmonox Medical, Inc.
Decision Date2003-08-14
Product CodeMRP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VIANOX DELIVERY SYSTEM, MODEL I is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonox Medical, Inc.. It received FDA 510(k) clearance on 2003-08-14 under 510(k) number K023014. The device is classified under product code MRP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIANOX DELIVERY SYSTEM, MODEL I?

VIANOX DELIVERY SYSTEM, MODEL I is a medical device that received FDA 510(k) clearance on 2003-08-14. The listed applicant is Pulmonox Medical, Inc.. The 510(k) number is K023014.

When did VIANOX DELIVERY SYSTEM, MODEL I receive FDA 510(k) clearance?

VIANOX DELIVERY SYSTEM, MODEL I received FDA 510(k) clearance on 2003-08-14, under 510(k) number K023014.

Who is the listed applicant for VIANOX DELIVERY SYSTEM, MODEL I?

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

What is the FDA product code for VIANOX DELIVERY SYSTEM, MODEL I?

The FDA product code for VIANOX DELIVERY SYSTEM, MODEL I is MRP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Pulmonox Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K033779VIANOX DELIVERY SYSTEM, MODEL II

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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