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
- K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)2Cleared 510(K)
- K243437mOm Essential Incubator (ME1)2Cleared 510(K)
- K213553Giraffe Incubator Carestation CS12Cleared 510(K)
- K190494Infant Incubator2Cleared 510(K)
- K182859Babyleo TN5002Cleared 510(K)
- K182977Isolette 8000 Plus2Cleared 510(K)
- K172154Isolette 8000 plus2Cleared 510(K)
- K162821Babyleo TN5002Cleared 510(K)
- K152814Giraffe OmniBed Carestation CS12Cleared 510(K)
- K152809Giraffe Incubator Carestation CS12Cleared 510(K)
- K132543INFANT INCUBATOR2Cleared 510(K)
- K102226DUAL INCU I2Cleared 510(K)
- K102279INCU I2Cleared 510(K)
- K102710NEO-SERVO I2Cleared 510(K)
- K101788GIRAFFE OMNIBED2Cleared 510(K)
- K101778GIRAFFE INCUBATOR2Cleared 510(K)
- K071977TARRY MEDICAL TEMPERATURE PROBES2Cleared 510(K)
- K072512MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)2Cleared 510(K)
- K070291MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX2Cleared 510(K)
- K071175OHMEDA MEDICAL GIRAFFE OMNIBED2Cleared 510(K)
- K061856V-2200 INFANT INCUBATOR2Cleared 510(K)
- K053399VERSALET 7700 CARE CENTER2Cleared 510(K)
- K061280V-2200 INFANT INCUBATOR2Cleared 510(K)
- K040910INFANT INCUBATOR, MODEL CHS-I10002Cleared 510(K)
- K040068BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K031387ISOLETTE INFANT INCUBATOR, MODEL C2000E2Cleared 510(K)
- K021809V-2100G ADVANCED INFANT INCUBATOR2Cleared 510(K)
- K020543OHMEDA MEDICAL GIRAFFE OMNIBED2Cleared 510(K)
- K020547OHMEDA MEDICAL GIRAFFE INCUBATOR2Cleared 510(K)
- K010222OHMEDA MEDICAL GIRAFFE INCUBATOR2Cleared 510(K)
- K003067CALEO2Cleared 510(K)
- K001242ISOLETTE INFANT INCUBATOR, MODEL C2HS2Cleared 510(K)
- K993051VERSALET 7700 CARE CENTER, MODEL # 77002Cleared 510(K)
- K993407OHMEDA MEDICAL OMNIBED2Cleared 510(K)
- K993712BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K980886BABYTHERM 8000 LDR2Cleared 510(K)
- K974349OHMEDA-OHIO CARE PLUS INCUBATOR2Cleared 510(K)
- K954204DRAGER INCUBATOR 8000 IC2Cleared 510(K)
- K962806OHMEDA-OHIO CAE PLUS INCUBATOR2Cleared 510(K)
- K960980ISOLETTE INFANT INCUBATOR2Cleared 510(K)
- K943360OHIO CARE PLUS INCUBATOR2Cleared 510(K)
- K940975C450/C400 INFANT INCUBATORS2Cleared 510(K)
- K924324K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE2Cleared 510(K)
- K922618BOWRON2Cleared 510(K)
- K920049MEDIX PC-305 NEONATAL INCUBATOR2Cleared 510(K)
- K924297DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER2Cleared 510(K)
- K924170ISOLETTE INCUBATOR HUMIDITY METER2Cleared 510(K)
- K912000TYPE INTERFACE 9271/1 INCUBATOR/WARMER2Cleared 510(K)
- K915752FIRST TOUCH/VILEDON NON-WOVEN FILTER2Cleared 510(K)
- K914864MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR2Cleared 510(K)
- K914487OHIO CARE PLUS INCUBATOR2Cleared 510(K)
- K914134INCUBATOR 8000 SC2Cleared 510(K)
- K913394INCUBATOR 8000 IC2Cleared 510(K)
- K913291MODEL C386 ISOLETTE(R) INFANT INCUBATOR2Cleared 510(K)
- K912909SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM2Cleared 510(K)
- K912910C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM2Cleared 510(K)
- K913154OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION2Cleared 510(K)
- K901157MP4, MP4SI, IT4 INCUBATORS2Cleared 510(K)
- K903378MODEL C286 ISOLETTE INFANT INCUBATOR2Cleared 510(K)
- K900752INCUBATOR 80002Cleared 510(K)
- K901585OHMEDA - OHIO(R) CARE PLUS INCUBATOR2Cleared 510(K)
- K900735MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR2Cleared 510(K)
- K895782NEONATAL INCUBATOR (ACCESSORY)2Cleared 510(K)
- K895550K-1 INFANT TRANSPORT SYSTEM2Cleared 510(K)
- K890476ADEL - MODEL 986 INFANT WARMER2Cleared 510(K)
- K881476PREEMICARE MODEL D1-X1, SERIES 30002Cleared 510(K)
- K884086C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR2Cleared 510(K)
- K870223AMEDA AMELETTE(R) NEONATAL INCUBATOR2Cleared 510(K)
- K870222AMEDA AMECARE(R) NEONATAL INCUBATOR2Cleared 510(K)
- K871399OHIO(R) CARE PLUS INCUBATOR2Cleared 510(K)
- K840526AMETHERM2Cleared 510(K)
- K832418OHIO TEMPERATURE SIMULATOR2Cleared 510(K)
- K822656C-200 INFANT INCUBATOR2Cleared 510(K)
- K821896C-300 INFANT INCUBATOR2Cleared 510(K)
- K813239OXYGENAIRE NURING INCUBATOR2Cleared 510(K)
- K813238NEOCARE BABY-CONTROLLED INCUBATOR2Cleared 510(K)
- K810792NEOCARE TEMPERATURE MONITOR2Cleared 510(K)
- K810067140 NEOCARE AIR CONTROLLED INCUBATOR2Cleared 510(K)
- K802640OHIO GC INCUBATOR2Cleared 510(K)
- K802639OHIO IC INCUBATOR2Cleared 510(K)
- K802126ISOLETTE INCUBATOR C-1002Cleared 510(K)
- K801461THERMA-SHIELD2Cleared 510(K)
- K781876ISOLETTE INCUBATOR2Cleared 510(K)
- K780472INFANT INCUBATOR2Cleared 510(K)
- 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
- 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
MODEL C386 ISOLETTE(R) INFANT INCUBATOR
- Page Type
- Cleared 510(K)
- 510(k) Number
- K913291
- 510(k) Type
- Traditional
- Applicant
- AIR-SHIELDS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/13/1991
- Days to Decision
- 112 days
- Submission Type
- Statement