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FDA 510(k)

RADKOR SFC-21

K-Number: K881701 · 1988-09-08

ApplicantRadkor, Inc.
Decision Date1988-09-08
Product CodeIYB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADKOR SFC-21 is the device name listed in this FDA 510(k) record. The listed applicant is Radkor, Inc.. It received FDA 510(k) clearance on 1988-09-08 under 510(k) number K881701. The device is classified under product code IYB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADKOR SFC-21?

RADKOR SFC-21 is a medical device that received FDA 510(k) clearance on 1988-09-08. The listed applicant is Radkor, Inc.. The 510(k) number is K881701.

When did RADKOR SFC-21 receive FDA 510(k) clearance?

RADKOR SFC-21 received FDA 510(k) clearance on 1988-09-08, under 510(k) number K881701.

Who is the listed applicant for RADKOR SFC-21?

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 SFC-21?

The FDA product code for RADKOR SFC-21 is IYB.

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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-159K883081RADKOR, XG-515

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Related Devices (Code: IYB)

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.

K935123SUPERSTAND 300Wuestec Medical, Inc.K946261MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000Scott Imaging Intl., Inc.K941004CTS SYSTEMAcoma Medical Imaging, Inc.K941017F/C/W TUBESTANDAcoma Medical Imaging, Inc.K940442MPR-814Xri, Inc.K935004MODEL ALPHA TS-2Dpa Consulting, 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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