FDA 510(k)

OX-600

K-Number: K920196 · 1992-10-14

Decision Date1992-10-14

Product CodeKPX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OX-600 is the device name listed in this FDA 510(k) record. The listed applicant is Stardard X-Ray Sales Co.. It received FDA 510(k) clearance on 1992-10-14 under 510(k) number K920196. 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 OX-600?

OX-600 is a medical device that received FDA 510(k) clearance on 1992-10-14. The listed applicant is Stardard X-Ray Sales Co.. The 510(k) number is K920196.

When did OX-600 receive FDA 510(k) clearance?

OX-600 received FDA 510(k) clearance on 1992-10-14, under 510(k) number K920196.

Who is the listed applicant for OX-600?

The FDA 510(k) record lists Stardard X-Ray Sales Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OX-600?

The FDA product code for OX-600 is KPX.

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 Indus K934850NUCLEAR 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.