Medical Device Manufacturer · US , Mchenry , IL

Rondex Products, Inc. - FDA 510(k) Cleared Devices

11 submissions · 10 cleared · Since 1984

11

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Rondex Products, Inc. Anesthesiology ✕

11 devices

1-11 of 11

Cleared May 19, 1998

RONDEX CPR ISO-SHIELD

Anesthesiology · 50d

Cleared Feb 07, 1995

Anesthesiology · 246d

Cleared Nov 10, 1994

NON-BREATHING VALVE

Anesthesiology · 100d

Cleared Oct 06, 1992

RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED

Anesthesiology · 224d

Cleared Nov 08, 1991

RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED

Anesthesiology · 64d

Cleared Nov 08, 1991

RONDEX MASKS MODELS 9015/9011/901102 MODIFIED

Anesthesiology · 64d

Cleared Oct 26, 1990

CPR VALVE (NON-REBREATHING) MODEL #9030

Anesthesiology · 157d

Cleared Aug 22, 1990

ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS

Anesthesiology · 92d

Cleared Jul 21, 1988

RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR

Anesthesiology · 73d

Cleared Apr 25, 1988

RONDEX RESCUE MASK

Anesthesiology · 21d

Cleared Jan 18, 1984

Anesthesiology · 42d