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FDA 510(k)

R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS)

K-Number: K800935 · 1980-05-23

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

Device Summary

R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) 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 K800935. 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 APEX-POST.,ANT.&POST. ELECT.(12 MODS)?

R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) 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 K800935.

When did R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) receive FDA 510(k) clearance?

R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) received FDA 510(k) clearance on 1980-05-23, under 510(k) number K800935.

Who is the listed applicant for R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS)?

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 APEX-POST.,ANT.&POST. ELECT.(12 MODS)?

The FDA product code for R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) 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 ELECTRODEK800932ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120K800936R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171K800931R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122K800930R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.K800937R2 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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