FDA 510(k)

R-800-SF

K-Number: K904182 · 1990-11-13

Decision Date1990-11-13

Product CodeITY

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

R-800-SF is the device name listed in this FDA 510(k) record. The listed applicant is Advantech. It received FDA 510(k) clearance on 1990-11-13 under 510(k) number K904182. The device is classified under product code ITY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R-800-SF?

R-800-SF is a medical device that received FDA 510(k) clearance on 1990-11-13. The listed applicant is Advantech. The 510(k) number is K904182.

When did R-800-SF receive FDA 510(k) clearance?

R-800-SF received FDA 510(k) clearance on 1990-11-13, under 510(k) number K904182.

Who is the listed applicant for R-800-SF?

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

What is the FDA product code for R-800-SF?

The FDA product code for R-800-SF is ITY.

Other records listing Advantech 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.

K900007R-100-ET MANUAL COLLIMATOR K896486R-150-ET COLLIMATOR

Related Devices (Code: ITY)

K000052X-RAY MONOBLOCK, MONOBLOCK XRS-60-330Dynarad Corp.K933162MRX-750Mrx Corp.K923094MOLYBDENUMSoutheastern Medical Diagnostics, Inc.K923141PHILIPS PRE-FILTER OPTIONPhilips Medical Systems, Inc.K921129MRX-700Mrx-Ray Tube Corp.K921130MRX-865Mrx-Ray Tube Corp.

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.