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FDA 510(k)

R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.

K-Number: K800930 · 1980-05-23

ApplicantR2 Corp.
Decision Date1980-05-23
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. is the device name listed in this FDA 510(k) record. The listed applicant is R2 Corp.. It received FDA 510(k) clearance on 1980-05-23 under 510(k) number K800930. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.?

R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. is a medical device that received FDA 510(k) clearance on 1980-05-23. The listed applicant is R2 Corp.. The 510(k) number is K800930.

When did R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. receive FDA 510(k) clearance?

R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. received FDA 510(k) clearance on 1980-05-23, under 510(k) number K800930.

Who is the listed applicant for R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.?

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(TM) ECG ELECTRODE SET-#'S305-306 ETC.?

The FDA product code for R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. is DRX.

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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 ELECTRODEK800936R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171K800935R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS)K800931R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122K800932ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120K800937R2 PLATE TYPE CABLE-ADAPTOR #S 175,176

View all 9 devices →

Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

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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