Medical Device Manufacturer · US , Mchenry , IL

R2 Corp. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1980

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - R2 Corp. Cardiovascular ✕

7 devices

1-7 of 7

Cleared Dec 16, 1983

MAGNATRODE CARDIAC MONITORING ELECTRODE

Cardiovascular · 141d

Cleared May 23, 1980

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

Cardiovascular · 32d

Cleared May 23, 1980

R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122

Cardiovascular · 32d

Cleared May 23, 1980

ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120

Cardiovascular · 32d

Cleared May 23, 1980

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

Cardiovascular · 32d

Cleared May 23, 1980

R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171

Cardiovascular · 32d

Cleared May 23, 1980

R2 PLATE TYPE CABLE-ADAPTOR #S 175,176

Cardiovascular · 32d