Medical Device Manufacturer · US , Corona Del Mar , CA

Pegasus Research Corp.

12 submissions · 12 cleared · Since 1988
12
Total
12
Cleared
0
Denied

Pegasus Research Corp. — FDA 510(k) Submissions

Pegasus Research Corp. has submitted 12 FDA 510(k) premarket notifications since 1988, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Humidifier, Respiratory Gas, (direct Patient Interface), Nebulizer (direct Patient Interface), Spirometer, Therapeutic (incentive), Drain, Tee (water Trap) . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
K122857 · CAF Nebulizer (direct Patient... · Anesthesiology
Nov 2012 50d
PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
K020700 · BTT Humidifier, Respiratory... · Anesthesiology
Apr 2004 784d
PMH 1000 HEATED HUMIDIFIER
K013856 · BTT Humidifier, Respiratory... · Anesthesiology
Feb 2003 472d
HEATED HUMIDIFIER
K983783 · BTT Humidifier, Respiratory... · Anesthesiology
Oct 2000 728d
THERA-MIST NEBULIZER MODEL-P3000
K962534 · CAF Nebulizer (direct Patient... · Anesthesiology
Feb 1997 245d
AQUALARM MOISTURE SENSOR MODEL P85000
K946057 · BYH Drain, Tee (water Trap) · Anesthesiology
May 1995 144d
AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED
K915890 · BTT Humidifier, Respiratory... · Anesthesiology
Jun 1992 183d
AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000
K914465 · CAF Nebulizer (direct Patient... · Anesthesiology
Mar 1992 176d
THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000
K903489 · BWF Spirometer, Therapeutic... · Anesthesiology
Dec 1990 130d
THERA-MIST(TM) NEBULIZER, MODEL 30000
K893942 · CAF Nebulizer (direct Patient... · Anesthesiology
Aug 1989 89d
THERA-MIST HUMIDIFIER
K894000 · BTT Humidifier, Respiratory... · Anesthesiology
Aug 1989 84d
AERO-MIST NEBULIZER HEATER
K880473 · CAF Nebulizer (direct Patient... · Anesthesiology
Mar 1988 56d
Filters
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