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FDA 510(k)

RADKOR BS-10 AND BS-10T

K-Number: K891395 · 1989-04-03

ApplicantRadkor, Inc.
Decision Date1989-04-03
Product CodeIXY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADKOR BS-10 AND BS-10T is the device name listed in this FDA 510(k) record. The listed applicant is Radkor, Inc.. It received FDA 510(k) clearance on 1989-04-03 under 510(k) number K891395. The device is classified under product code IXY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADKOR BS-10 AND BS-10T?

RADKOR BS-10 AND BS-10T is a medical device that received FDA 510(k) clearance on 1989-04-03. The listed applicant is Radkor, Inc.. The 510(k) number is K891395.

When did RADKOR BS-10 AND BS-10T receive FDA 510(k) clearance?

RADKOR BS-10 AND BS-10T received FDA 510(k) clearance on 1989-04-03, under 510(k) number K891395.

Who is the listed applicant for RADKOR BS-10 AND BS-10T?

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 BS-10 AND BS-10T?

The FDA product code for RADKOR BS-10 AND BS-10T is IXY.

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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-BK883864RADKOR SFR-70K883885RADKOR, RF-159K881701RADKOR SFC-21K881696RADKOR XG-325

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Related Devices (Code: IXY)

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.

K953336VRS 3 WALL STANDPhilips Medical Systems (Cleveland), Inc.K953402UNIVERSIX 190Philips Medical Systems (Cleveland), Inc.K946114SENSORI-MOTOR RATING SCALECmedK946260NTBS-1417, 1436, TBS-1417Scott Imaging Intl., Inc.K930249BC/WT/PFTingle X-Ray Products, Inc.K930230RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDERAmerican Medical Sales, 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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