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FDA 510(k)

RADKOR KOB-84

K-Number: K881700 · 1988-09-02

ApplicantRadkor, Inc.
Decision Date1988-09-02
Product CodeKXJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADKOR KOB-84 is the device name listed in this FDA 510(k) record. The listed applicant is Radkor, Inc.. It received FDA 510(k) clearance on 1988-09-02 under 510(k) number K881700. The device is classified under product code KXJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADKOR KOB-84?

RADKOR KOB-84 is a medical device that received FDA 510(k) clearance on 1988-09-02. The listed applicant is Radkor, Inc.. The 510(k) number is K881700.

When did RADKOR KOB-84 receive FDA 510(k) clearance?

RADKOR KOB-84 received FDA 510(k) clearance on 1988-09-02, under 510(k) number K881700.

Who is the listed applicant for RADKOR KOB-84?

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

What is the FDA product code for RADKOR KOB-84?

The FDA product code for RADKOR KOB-84 is KXJ.

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Other records listing Radkor, 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.

K895969RADKOR DXG-650RK892196RADKOR TS10-BK891395RADKOR BS-10 AND BS-10TK883864RADKOR SFR-70K883885RADKOR, RF-159K881701RADKOR SFC-21

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Related Devices (Code: KXJ)

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.

K050190APOLLOVilla Sistemi Medicali S.P.A.K963905RADIOGRAPHIC ITT TABLEX-Ray Technologies, Inc.K955414XRT 400Wuestec Medical, Inc.K951146IMAGING TABLESepta Corp.K950068CARBON FIBER COUCH INSERTMedtec, Inc.K950442INFRARED EXPOSURE HAND SWITCHMedical X-Ray Intl., Inc.

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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