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
- K243606Babyroo TN3002Cleared 510(K)
- K230278Babyroo TN3002Cleared 510(K)
- K213551Giraffe Omnibed Carestation CS12Cleared 510(K)
- K201628Panda iRes Warmer, Giraffe Warmer2Cleared 510(K)
- K200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable2Cleared 510(K)
- K191425Hydro-Temp Neonatal Skin Temperature Probe Cover2Cleared 510(K)
- K173516NuBorne Infant Warmer2Cleared 510(K)
- K123309GIRAFFE AND PANDA WARMERS2Cleared 510(K)
- K120642RESUSCITAIRE WITH AUTOBREATH2Cleared 510(K)
- K122267GIRAFFE AND PANDA WARMERS2Cleared 510(K)
- K121625LULLABY TM WARMER2Cleared 510(K)
- K120937SUNFLOWER WARNER2Cleared 510(K)
- K102227INFA WARMER I2Cleared 510(K)
- K101804GIRAFFE AND PANDA WARMERS2Cleared 510(K)
- K090697MODIFICATION TO: GIRAFFE AND PANDA WARMER2Cleared 510(K)
- K072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)2Cleared 510(K)
- K070377GIRAFFE AND PANDA WARMER2Cleared 510(K)
- K060461V-505 INFA WARMER2Cleared 510(K)
- K033040PHOENIX INFANT RADIANT WARMER, MODEL 100NWS2Cleared 510(K)
- K020966RPI REPLACEMENT HEATING ELEMENTS2Cleared 510(K)
- K020219RPI SKIN OR AIR TEMPERATURE PROBE2Cleared 510(K)
- K012229SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC2Cleared 510(K)
- K003335RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER2Cleared 510(K)
- K002355ATOM INFA WARMER V-5052Cleared 510(K)
- K971366INCUWARMER2Cleared 510(K)
- K972885SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW9702Cleared 510(K)
- K971198BABYTHERM 8004 BABYTHERM 80102Cleared 510(K)
- K970686ACCUTEMP-PROBE2Cleared 510(K)
- K971695SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER2Cleared 510(K)
- K971461SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)2Cleared 510(K)
- K970432INFANT RADIANT WARMER - MODELS IW910 AND IW9202Cleared 510(K)
- K970074STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)2Cleared 510(K)
- K964401KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)2Cleared 510(K)
- K950422FIRST TOUCH DISPOSABLES TEMPERATURE PROBES2Cleared 510(K)
- K963058INFANT WARMER SYSTEM2Cleared 510(K)
- K960080ACCUTEMP PROBE2Cleared 510(K)
- K952803TEMPERATURE PROBE-TP3502Cleared 510(K)
- K952804TEMPERATURE PROBE-TP4502Cleared 510(K)
- K952800TEMPERATURE PROBE-TP1502Cleared 510(K)
- K952807TEMPERATURE PROBE-TP6502Cleared 510(K)
- K952805TEMPERATURE PROBE-TP5502Cleared 510(K)
- K952801TEMPERATURE PROBE-TP2502Cleared 510(K)
- K953489DRAGER INFANT RADIANT WARMERN RH6002Cleared 510(K)
- K950143ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE2Cleared 510(K)
- K946005ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE2Cleared 510(K)
- K940951RW RESUCITAIRE INFANT RADIANT WARMER2Cleared 510(K)
- K942905DISPOSABLE TEMPERATURE PROBE COVER2Cleared 510(K)
- K942904STABILET2Cleared 510(K)
- K934677U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE2Cleared 510(K)
- K9356094002 INFANT SCALE FOR INCUBATORS AND WARMERS2Cleared 510(K)
- K931529INFANT WARMER2Cleared 510(K)
- K926030KLEAR-TEMP2Cleared 510(K)
- K925006HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO2Cleared 510(K)
- K921547ADVANTAGE2Cleared 510(K)
- K921766OHIO INFANT WARMER SYSTEM2Cleared 510(K)
- K912921VSI 10002Cleared 510(K)
- K915831THERMAL PROBE COVER2Cleared 510(K)
- K913945STABILET INFANT RADIANT WARMER MODEL 2000C2Cleared 510(K)
- K910915PATIENT WARMER MODEL 100C2Cleared 510(K)
- K885350PREEMICARE SERIES 2000 INFANT WARMER2Cleared 510(K)
- K884283MODEL WC-107 MOBILE NEWBORN BED2Cleared 510(K)
- K884285MODEL WC-115 MOBILE BASSINET2Cleared 510(K)
- K884280MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET2Cleared 510(K)
- K881670ACCUTEMP PLUS2Cleared 510(K)
- K884160OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM2Cleared 510(K)
- K881713SPECIAL PROCEDURES BASE UNIT MODEL 5002Cleared 510(K)
- K875270INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS2Cleared 510(K)
- K872742WARM WEIGH MODELS I-20/W-30 INFANT SCALE2Cleared 510(K)
- K871177NTH 101 UL2Cleared 510(K)
- K871178MTC XI UL2Cleared 510(K)
- K871594BIRTHING ROOM WARMER2Cleared 510(K)
- K862921MODEL 10200 PREMATURE INFANT INCUBATOR2Cleared 510(K)
- K865012YSI MODEL 8012Cleared 510(K)
- K863208OHMEDA AUXILIARY POWER SYSTEM2Cleared 510(K)
- K861781DELIVERY ROOM WARMER2Cleared 510(K)
- K853926NEOCARE MODEL 800 INFANT RADIANT WARMER2Cleared 510(K)
- K852943NEO SHIELD2Cleared 510(K)
- K853351OHMEDA HEAT REFLECTING PATCH2Cleared 510(K)
- K853794NEOGUARD REFLECTOR2Cleared 510(K)
- K851449OHMEDA 5000 INFANT WARMER SYSTEM2Cleared 510(K)
- K850069BORNING NEONATAL RESUSCITATOIN CENTER2Cleared 510(K)
- K840792INFANT RADIANT WARMER2Cleared 510(K)
- K833802INFANT WARMER2Cleared 510(K)
- K840858OHIO 3300 INFANT WARMER SYSTEM2Cleared 510(K)
- K840857OHIO 3000 INFANT WARMER SYSTEM2Cleared 510(K)
- K832637AMEDA NEONATAL RESUSCITATION UNIT-2Cleared 510(K)
- K830748RESUSCITAIRE2Cleared 510(K)
- K813408SAGE 2200 STERILE SPECIMEN CONTAINER2Cleared 510(K)
- K812745WARMING LISTHTS #96H & 96HT2Cleared 510(K)
- K802365OHIO RADIANT WARMER2Cleared 510(K)
- K790948TEMP-GUARD TM2Cleared 510(K)
- K790137INFANT CARE SYSTEM2Cleared 510(K)
- 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
- 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
BABYTHERM 8004 BABYTHERM 8010
- Page Type
- Cleared 510(K)
- 510(k) Number
- K971198
- 510(k) Type
- Traditional
- Applicant
- DRAGER, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/3/1997
- Days to Decision
- 186 days
- Submission Type
- Summary