Medical Device Manufacturer · US , Mchenry , IL

Hans Rudolph, Inc.

11 submissions · 11 cleared · Since 1979
11
Total
11
Cleared
0
Denied

Hans Rudolph, Inc. — FDA 510(k) Submissions

Hans Rudolph, Inc. has submitted 11 FDA 510(k) premarket notifications since 1979, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ventilator, Non-continuous (respirator), Mask, Oxygen, Non-rebreathing, Mask, Gas, Anesthetic, Calculator, Pulmonary Function Data, Mask, Oxygen . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
HRI 6500, 6600 AND 6700 SERIES V2MASKS
K071149 · BZD Ventilator,... · Anesthesiology
Feb 2008 283d
7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS
K030822 · BZD Ventilator,... · Anesthesiology
Jun 2003 81d
HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS
K030515 · CBK Ventilator, Continuous,... · Anesthesiology
May 2003 72d
7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT
K020759 · BZD Ventilator,... · Anesthesiology
Aug 2002 159d
HANS RUDOLPH NASAL CPAP MASK
K962848 · BYG Mask, Oxygen · Anesthesiology
Oct 1996 86d
ULTIMATE SEAL
K960401 · KGB Mask, Oxygen,... · Anesthesiology
Jun 1996 143d
DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS
K946077 · BZC Calculator, Pulmonary... · Anesthesiology
Sep 1995 276d
MASK, GAS, ANESTHETIC
K945894 · BSJ Mask, Gas, Anesthetic · Anesthesiology
Jan 1995 56d
NONREBREATHING VALVE
K933583 · KGB Mask, Oxygen,... · Anesthesiology
Jan 1994 164d
NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE
K932147 · BSJ Mask, Gas, Anesthetic · Anesthesiology
Aug 1993 108d
4200 PNEUMATIC MOUTH SHUTTER
K791705 · CCM Plethysmograph, Pressure · Anesthesiology
Oct 1979 37d
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