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FDA 510(k)

R2 ESU CABLE-ADAPTER MODELS 160,161

K-Number: K800934 · 1980-05-20

ApplicantR2 Corp.
Decision Date1980-05-20
Product CodeIKD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

R2 ESU CABLE-ADAPTER MODELS 160,161 is the device name listed in this FDA 510(k) record. The listed applicant is R2 Corp.. It received FDA 510(k) clearance on 1980-05-20 under 510(k) number K800934. The device is classified under product code IKD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R2 ESU CABLE-ADAPTER MODELS 160,161?

R2 ESU CABLE-ADAPTER MODELS 160,161 is a medical device that received FDA 510(k) clearance on 1980-05-20. The listed applicant is R2 Corp.. The 510(k) number is K800934.

When did R2 ESU CABLE-ADAPTER MODELS 160,161 receive FDA 510(k) clearance?

R2 ESU CABLE-ADAPTER MODELS 160,161 received FDA 510(k) clearance on 1980-05-20, under 510(k) number K800934.

Who is the listed applicant for R2 ESU CABLE-ADAPTER MODELS 160,161?

The FDA 510(k) record lists R2 Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R2 ESU CABLE-ADAPTER MODELS 160,161?

The FDA product code for R2 ESU CABLE-ADAPTER MODELS 160,161 is IKD.

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Other records listing R2 Corp. 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.

K832516MAGNATRODE CARDIAC MONITORING ELECTRODEK800932ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120K800936R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171K800935R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS)K800930R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.K800937R2 PLATE TYPE CABLE-ADAPTOR #S 175,176

View all 9 devices →

Related Devices (Code: IKD)

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.

K070926ELECTRODE/EXTENSION CABLES, MODELS ATAROscor, Inc.K992372THE LEADAWAYTherapy Equipment, Inc.K935260PHYSIOMETRIX CABLE ADAPTER MODIFICATIONPhysiometrix, Inc.K873361LIFE-SPAN CABLEChemfet Corp.K834583CLEAR LEADS-RADIOTRANSPARENT WIRESQuinton, 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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