Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- BRZSet, Blood Transfusion2Product Code
- BWJLocator, Acupuncture Point2Product Code
- CAKMicrofilter, Blood Transfusion2Product Code
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)2Product Code
- FMFSyringe, Piston2Product Code
- FMGStopcock, I.V. Set2Product Code
- FMINeedle, Hypodermic, Single Lumen2Product Code
- FMSBed, Pediatric Open Hospital2Product Code
- FMTWarmer, Infant Radiant2Product Code
- FMZIncubator, Neonatal2Product Code
- FNGLift, Patient, Ac-Powered2Product Code
- FNJBed, Manual1Product Code
- FNKBed, Hydraulic, Adjustable Hospital1Product Code
- FNLBed, Ac-Powered Adjustable Hospital2Product Code
- FNMMattress, Air Flotation, Alternating Pressure2Product Code
- K973169PRESSURE GUARD SITE SELECT (A)2Cleared 510(K)
- K974319MIGHTY AIR2Cleared 510(K)
- K972022ZAK-20002Cleared 510(K)
- K974070PHYSIO/10002Cleared 510(K)
- K972549SIMPULSE2Cleared 510(K)
- K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM2Cleared 510(K)
- K955243BARIAIR2Cleared 510(K)
- K970468KT AIR BED2Cleared 510(K)
- K965207RID-DECUBE II2Cleared 510(K)
- K972153ALTERNATING PRESSURE AIR FLOTATION MATTRESS2Cleared 510(K)
- K971568REST MATTRESS2Cleared 510(K)
- K954320MODIFIED PEDIKAIR2Cleared 510(K)
- K970362CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM2Cleared 510(K)
- K970428REST X SYSTEM2Cleared 510(K)
- K970350EQUI-PISE 1000 MRS2Cleared 510(K)
- K963674LUMEX AIR2Cleared 510(K)
- K9636209TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS2Cleared 510(K)
- K962585UNIT-MATT 5000 PRESSURE RELIEF SYSTEM2Cleared 510(K)
- K9636779TH WAVE MODEL 200 ALTERNATING PRESSURE PAD2Cleared 510(K)
- K9636269TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS2Cleared 510(K)
- K963510APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM2Cleared 510(K)
- K961769AIR-MEDEX I2Cleared 510(K)
- K960188PRESSUREGUARD: SELECTCARE2Cleared 510(K)
- K961854SPR PLUS II OVERLAY SYSTEM (CL250/CL2122Cleared 510(K)
- K962123AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM2Cleared 510(K)
- K961159POWERED LOW AIR LOSS MATTRESS SYSTEM2Cleared 510(K)
- K960620PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM2Cleared 510(K)
- K961129AREMA II2Cleared 510(K)
- K955874ALTACARE2Cleared 510(K)
- K960411MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS2Cleared 510(K)
- K954593THE AIRCEL SYSTEM2Cleared 510(K)
- K954766PRESSURE GUARD ALTERNATING PRESSURE MATTRESS2Cleared 510(K)
- K953196CARDIO-SYSTEMS PRO-OP2Cleared 510(K)
- K953503PRESSUREGUARD IV2Cleared 510(K)
- K953675ALTADYNE2Cleared 510(K)
- K952610PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500)2Cleared 510(K)
- K953069AMERIMED AS1102Cleared 510(K)
- K952092ERGOMAT 8000 SYSTEM2Cleared 510(K)
- K952093ERGOMAT 5000 SYSTEM2Cleared 510(K)
- K951469BAZOOKA SYSTEM2Cleared 510(K)
- K950191THE LOTECON PERSONAL CARE SYSTEM2Cleared 510(K)
- K951112PRESSUREGUARD IV2Cleared 510(K)
- K944094TRIADYNE2Cleared 510(K)
- K945845MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT2Cleared 510(K)
- K945629MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS2Cleared 510(K)
- K944310PEGASUS BIWAVE PLUS SYSTEM2Cleared 510(K)
- K945041PARAGON PORTABLE2Cleared 510(K)
- K943162LAKE STAGEZERO(TM) AIR FLOTATION BED2Cleared 510(K)
- K941083DYNAMEDICS ASAR2Cleared 510(K)
- K944411P/20002Cleared 510(K)
- K943097CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM2Cleared 510(K)
- K943353PLEXUS/10002Cleared 510(K)
- K942920MEDAIR EXCEL 20002Cleared 510(K)
- K935949STRYKER 50002Cleared 510(K)
- K934817SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS2Cleared 510(K)
- K933965APEX MEDICAL AIR PUMPS2Cleared 510(K)
- K933402TURBO II2Cleared 510(K)
- K933004PEGASUS BIWAVE SYSTEM2Cleared 510(K)
- K933091STAGE IV, CM-4000,MATTRESS OVERLAY SYSTEM2Cleared 510(K)
- K932681PRESSUREGUARD IV2Cleared 510(K)
- K930673PREMIUM2Cleared 510(K)
- K926403PRO-2000 LOW AIR LOSS THERAPY BED2Cleared 510(K)
- K926045SKYTRON LIFE ISLAND 212Cleared 510(K)
- K925651LIFE ISLAND 212Cleared 510(K)
- K924005SANKEN MAT2Cleared 510(K)
- K915306THE KAUFMANN LIFT-AND-TURN MATTRESS2Cleared 510(K)
- K922205BIO THERAPY PLUS2Cleared 510(K)
- K914775TALLEY MICRO SYSTEM/TALLEY RIPPLEBED2Cleared 510(K)
- K915061PROACT CLA-1500 SYSTEM2Cleared 510(K)
- K913933TURNSOFT MATTRESS2Cleared 510(K)
- K901901PROFILE, A CRITICAL CARE LOW AIR LOSS BED2Cleared 510(K)
- K901096LUMISCOPE ALTERNATING PRESSURE PAD & PUMP2Cleared 510(K)
- K900871ALTERNATING PRESSURE PUMP AND PAD SYSTEM2Cleared 510(K)
- K900131BIO FLOTE(R)2Cleared 510(K)
- K891259MODEL 4000 ALTERNATING PRESSURE PUMP AND PAD2Cleared 510(K)
- K891457DR. VOLKNER'S LAMELLAR TURNING BED(TM)2Cleared 510(K)
- K890012HUNTLEIGH DYNAMIC FLOTATION SYSTEM2Cleared 510(K)
- K883256BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM2Cleared 510(K)
- K882644HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP52Cleared 510(K)
- K882092CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM2Cleared 510(K)
- K882161ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM2Cleared 510(K)
- K874877PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER2Cleared 510(K)
- K874801ORTHODERM THERAPY BED2Cleared 510(K)
- K871705LOW AIR LOSS BED2Cleared 510(K)
- K872228PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM2Cleared 510(K)
- K870681HUNTLEIGH BETA II HM852Cleared 510(K)
- K863152MEDSENTRY FLOTATION SYSTEM2Cleared 510(K)
- K850419AUTO TURNER2Cleared 510(K)
- K844499MEDSENTRY SOFTOUCH SYSTEM2Cleared 510(K)
- K844880HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES2Cleared 510(K)
- K844879HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP2Cleared 510(K)
- K833964PEGASUS MATTRESS2Cleared 510(K)
- K813407AIR MATTRESS2Cleared 510(K)
- K811684AMERICAN AIRCARE SYSTEM2Cleared 510(K)
- K803307MATTRESS, AIR FLOATATION, ALTERN. PRESS.2Cleared 510(K)
- K800231ABCO/GRANT ALTERNATING PRESSURE PAD & UT2Cleared 510(K)
- K792001COMFICARE PAD (FOR SINGEL PT USE)2Cleared 510(K)
- K781404BED PADS: D-12 AND D-82Cleared 510(K)
- K780906AIR-FLO ALTERNATING PRESSURE PAD SYSTEM2Cleared 510(K)
- K780502NOVA AIR FLOATATION SYSTEM2Cleared 510(K)
- K771463AERO PULSE ALTERNATING PRES. PUMP2Cleared 510(K)
- K761012ALPHABED ALTERNATING PRESSURE PAD2Cleared 510(K)
- FNNNipple, Lambs Feeding1Product Code
- FODDevice, Occlusion, Umbilical1Product Code
- FOHMattress, Water, Temperature Regulated1Product Code
- FOKPad, Neonatal Eye1Product Code
- FOSCatheter, Umbilical Artery2Product Code
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2Product Code
- FPASet, Administration, Intravascular2Product Code
- FPBFilter, Infusion Line2Product Code
- FPKTubing, Fluid Delivery2Product Code
- FPLIncubator, Neonatal Transport2Product Code
- FQHLavage, Jet2Product Code
- FQJSupport, Scrotal, Therapeutic1Product Code
- FQKBinder, Perineal1Product Code
- FQLStocking, Medical Support (For General Medical Purposes)1Product Code
- FQMBandage, Elastic1Product Code
- FRFCleaner, Air, Medical Recirculating2Product Code
- FRLFiber, Medical, Absorbent1Product Code
- FRNPump, Infusion2Product Code
- FRPHolder, Infant Position1Product Code
- FRRChamber, Reverse Isolation, Patient Care2Product Code
- FSALift, Patient, Non-Ac-Powered1Product Code
- FSDBinder, Abdominal1Product Code
- HEFBinder, Breast1Product Code
- HFSShield, Nipple1Product Code
- IKYMattress, Flotation Therapy, Non-Powered1Product Code
- KMKDevice, Intravascular Catheter Securement1Product Code
- KMOBinder, Elastic1Product Code
- KPEContainer, I.V.2Product Code
- KYPSnake Bite Suction Kit1Product Code
- KYQKit, Chemical Snake-Bite3Product Code
- KZDInfusor, Pressure, For I.V. Bags1Product Code
- KZEInjector, Fluid, Non-Electrically Powered2Product Code
- LBIUnit, Neonatal Phototherapy2Product Code
- LDRController, Infusion, Intravascular, Electronic2Product Code
- LGMChamber, Patient Isolation2Product Code
- LGNChamber, Patient Transport Isolation2Product Code
- LGZWarmer, Thermal, Infusion Fluid2Product Code
- LHFWarmer, Microwave, Infusion Fluid2Product Code
- LHISet, I.V. Fluid Transfer2Product Code
- LJLDetectors And Removers, Lice, (Including Combs)1Product Code
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2Product Code
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular2Product Code
- LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use2Product Code
- LLKLegging, Compression, Non-Inflatable2Product Code
- LZHPump, Infusion, Enteral2Product Code
- MDRBinder, Medical, Therapeutic1Product Code
- MEAPump, Infusion, Pca2Product Code
- MEBPump, Infusion, Elastomeric2Product Code
- MEGSyringe, Antistick2Product Code
- MHCNeedle, Interosseous2Product Code
- MHDPump, Infusion, Gallstone Dissolution2Product Code
- MJFCheck Valve, Retrograde Flow (In-Line)2Product Code
- MMKContainer, Sharps2Product Code
- MQXNeedle, Acupuncture, Single Use2Product Code
- MRZAccessories, Pump, Infusion2Product Code
- MZRTopical Approximation System1Product Code
- NEPSystem/Device, Pharmacy Compounding2Product Code
- NGTSaline, Vascular Access Flush2Product Code
- NKKNeedle, Hypodermic, Single Lumen, Reprocessed2Product Code
- NKNSyringe, Piston, Reprocessed2Product Code
- NRWStimulator, Intramuscular, Automatic2Product Code
- NSCInjector, Pen2Product Code
- NTCNursing Pad, Hydrogel1Product Code
- NTXNursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)1Product Code
- NXHNursing Pad, Cohesive Gel1Product Code
- NZGBassinet, Hospital2Product Code
- NZWHeparin, Vascular Access Flush2Product Code
- NZXWater, Vascular Access Flush2Product Code
- OBKPort, Protector/Cushion2Product Code
- ODIAdministration Set Docking Station2Product Code
- ODYTunneled Catheter Remover2Product Code
- OJAIntravenous Extension Tubing Set2Product Code
- OKCImplanted Subcutaneous Securement Catheter2Product Code
- OKEPort Introducer Kit2Product Code
- OKLIntravascular Administration Set, Automated Air Removal System2Product Code
- OMFPercutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position2Product Code
- ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System2Product Code
- ONMRadiant Infant Warmer Cabinet2Product Code
- PUKAdministration Set Securement Device1Product Code
- OPPPump, Infusion, Insulin Bolus2Product Code
- OSIBariatric Bed2Product Code
- OUWInfant Positioner, Rx, Use In Highly Monitored Setting1Product Code
- OWLPeripheral Catheter Insertion Kit2Product Code
- PDHBlanket, Neonatal Phototherapy2Product Code
- PEFHeparin Flush In 0.45% Sodium Chloride2Product Code
- PEZCentral Venous Catheter Dressing Change Kit2Product Code
- PHCInfusion Safety Management Software2Product Code
- PKPImmunoglobulin G (Igg) Infusion System2Product Code
- PMSPeripheral Intravenous (Piv) Infiltration Monitor2Product Code
- PNDMidline Catheter2Product Code
- POQBlood Transfusion Kit2Product Code
- PORParenteral Administration Kit2Product Code
- PQHIodinated Contrast Media Transfer Tubing Set2Product Code
- PQXEpinephrine Syringe2Product Code
- PRNPediatric Position Holder1Product Code
- PTDSubcutaneous Implanted Apheresis Port2Product Code
- PTINon-Coring (Huber) Needle2Product Code
- PUNLice Removal Kit Containing A Solution1Product Code
- PURVacuum Syringe2Product Code
- PVZNon-Stainless Steel Needle2Product Code
- PWHAdministrations Sets With Neuraxial Connectors2Product Code
- PWNBaby Care Kit2Product Code
- PWOBlood Administration Kit2Product Code
- PWQBuret Administration Intravenous Kit2Product Code
- PWRCatheter Repair Kit2Product Code
- PWXInsect Sting Emergency Kit1Product Code
- PWYLumbar Puncture Tray (Adult & Pediatric)2Product Code
- PXBPercutaneous Introducer Kit2Product Code
- PXIThoracentesis Tray2Product Code
- PXJUmbilical Catheter Insertion Tray2Product Code
- PXKVascular Access Port Kit2Product Code
- PXLVenipuncture Kit2Product Code
- PYRNeuraxial Administration Set - Intrathecal Delivery2Product Code
- PZWCatheter Access Cover, Tamper-Resistant2Product Code
- QBLPiston Syringe Lever2Product Code
- QDMMidazolam Syringe2Product Code
- QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact2Product Code
- QJYInfusion Pump, Drug Specific, Pharmacy-Filled2Product Code
- QLFOn-Body Injector2Product Code
- QLYOphthalmic Syringe2Product Code
- QMTPrep Kit – Vaccine Injection2Product Code
- QNQLow Dead Space Piston Syringe2Product Code
- QNSLow Dead Space Needle, Single Lumen, Hypodermic2Product Code
- QOGInjection Data Capture Device2Product Code
- QOIIntravenous Catheter Force-Activated Separation Device.2Product Code
- QTISaline Vascular Access Flush With Integrated Alcohol Disinfectant Device2Product Code
- QYMOphthalmic Needle2Product Code
- SCLAllergen And Vaccine Delivery Needles2Product Code
- SEFCentral Venous Catheter With Manual Insertion System2Product Code
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PEGASUS BIWAVE PLUS SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K944310
- 510(k) Type
- Traditional
- Applicant
- PEGASUS AIRWAVE, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/17/1995
- Days to Decision
- 196 days
- Submission Type
- Statement