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FDA 510(k)

RADX VENT-AL MECHANICAL RESPORATOR

K-Number: K800751 · 1980-05-08

ApplicantRadx Corp.
Decision Date1980-05-08
Product CodeKPX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADX VENT-AL MECHANICAL RESPORATOR is the device name listed in this FDA 510(k) record. The listed applicant is Radx Corp.. It received FDA 510(k) clearance on 1980-05-08 under 510(k) number K800751. The device is classified under product code KPX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADX VENT-AL MECHANICAL RESPORATOR?

RADX VENT-AL MECHANICAL RESPORATOR is a medical device that received FDA 510(k) clearance on 1980-05-08. The listed applicant is Radx Corp.. The 510(k) number is K800751.

When did RADX VENT-AL MECHANICAL RESPORATOR receive FDA 510(k) clearance?

RADX VENT-AL MECHANICAL RESPORATOR received FDA 510(k) clearance on 1980-05-08, under 510(k) number K800751.

Who is the listed applicant for RADX VENT-AL MECHANICAL RESPORATOR?

The FDA 510(k) record lists Radx Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADX VENT-AL MECHANICAL RESPORATOR?

The FDA product code for RADX VENT-AL MECHANICAL RESPORATOR is KPX.

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Related Devices (Code: KPX)

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.

K945635TRANS X-1000Canon USA, Inc.K935157ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBESRegulatory Consultants TO the Medical Device IndusK934850NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDSVictoreen, Inc.K933035BCM-600TXB C Medical , Ltd.K925598BUCKYMATIC AUTOMATIC CHEST FILM CHANGERAcoma Medical Imaging, Inc.K924423MWX-7440 HIGH SPEED BUCKYMidwest X-Ray Equipment Co.

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.

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