Medical Device Manufacturer · US , Mchenry , IL

Hans Rudolph, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1979

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hans Rudolph, Inc. Anesthesiology ✕

11 devices

1-11 of 11

Cleared Feb 01, 2008

HRI 6500, 6600 AND 6700 SERIES V2MASKS

Anesthesiology · 283d

Cleared Jun 03, 2003

7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS

Anesthesiology · 81d

Cleared May 02, 2003

HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS

Anesthesiology · 72d

Cleared Aug 13, 2002

7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630...

Anesthesiology · 159d

Cleared Oct 16, 1996

HANS RUDOLPH NASAL CPAP MASK

Anesthesiology · 86d

Cleared Jun 20, 1996

Anesthesiology · 143d

Cleared Sep 15, 1995

DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS

Anesthesiology · 276d

Cleared Jan 27, 1995

MASK, GAS, ANESTHETIC

Anesthesiology · 56d

Cleared Jan 03, 1994

NONREBREATHING VALVE

Anesthesiology · 164d

Cleared Aug 20, 1993

NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE

Anesthesiology · 108d

Cleared Oct 04, 1979

4200 PNEUMATIC MOUTH SHUTTER

Anesthesiology · 37d