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
- K202964iBed Wireless with iBed Mobile2Cleared 510(K)
- K103536IBED WIRELESS WITH IBED AWARENESS2Cleared 510(K)
- K982783VAIL 1000 ENCLOSED BED2Cleared 510(K)
- K974296MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED2Cleared 510(K)
- K974254BENEFIT B3--- SERIES2Cleared 510(K)
- K972115VOLKER HOSPITAL BED, MODEL K9602Cleared 510(K)
- K971546SOMA 900 TRANSPORT BED2Cleared 510(K)
- K963622VAIL 2000 ENCLOSED BED2Cleared 510(K)
- K963589VAIL 3000 BED ENCLOSURE2Cleared 510(K)
- K962942TOTALCARE2Cleared 510(K)
- K963701SOMA SAFE ENCLOSURE2Cleared 510(K)
- K964246NOVABED PATIENT TRANSFER SYSTEM2Cleared 510(K)
- K964515ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD30022Cleared 510(K)
- K962250CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED2Cleared 510(K)
- K9627632000 MODULAR THIRTY-NINE2Cleared 510(K)
- K951514SSC MODEL 4000 SERIES2Cleared 510(K)
- K951735JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL2Cleared 510(K)
- K951161MC ACCLAIM Q6000 BED2Cleared 510(K)
- K945042ELITE 3 LOW AIR LOSS BED2Cleared 510(K)
- K946208VOLKER NURSING BED MODEL 2080E & 2090E2Cleared 510(K)
- K946149STRYKER AGILITY INTENSIVE CARE BED2Cleared 510(K)
- K945664BARIKARE PLUS2Cleared 510(K)
- K935837AIRHYTHM HEALTHCARE BED2Cleared 510(K)
- K934090S.S.C. MEDICAL MODEL 5000 SERIES BED2Cleared 510(K)
- K932663MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES2Cleared 510(K)
- K930703ADJUSTABLE BED2Cleared 510(K)
- K931581GLENN BED2Cleared 510(K)
- K931482STRYKER MPS ACUTE CARE BED2Cleared 510(K)
- K926435COMFORTADE2Cleared 510(K)
- K930234FLH1768M SERIES HOSPITAL BED2Cleared 510(K)
- K925576BURKE BARIATRIC TREATMENT SYSTEM II2Cleared 510(K)
- K925534FULL/SEMI ELECTRIC HOME CARE BED2Cleared 510(K)
- K922352THE ADVANCE SERIES FROM HILL-ROM2Cleared 510(K)
- K915437CRITICAL CARE HOSPITAL BED (ICU/CCU)2Cleared 510(K)
- K911893EASY ACCESS BED2Cleared 510(K)
- K903904SERIES 2000 ADJUSTABLE BED2Cleared 510(K)
- K902183S.S.C. MEDICAL PRODUCTS HOME HEALTH CARE BED2Cleared 510(K)
- K900151INVACARE EXTENDED CARE NURSING HOME BED2Cleared 510(K)
- K894296PREMISE SERIES BED2Cleared 510(K)
- K893745THE INDEPENDENT CARE UNIT2Cleared 510(K)
- K890845PREMISE SERIES BED2Cleared 510(K)
- K890293AIDE-A-PATIENT (NURSING HOME BED)2Cleared 510(K)
- K890426CONSUMMATE AIR THERAPY BED2Cleared 510(K)
- K881960MSI STANDARD BED MODELS L1098-84/L1098-74/L1085-742Cleared 510(K)
- K883463HOSPITAL BED CLOTHING CRADLE2Cleared 510(K)
- K881844MAGNUM 800(TM) MANAGEMENT SYSTEM2Cleared 510(K)
- K881782MSI 4000 SERIES BED2Cleared 510(K)
- K881963MSI 3002 SERIES BED2Cleared 510(K)
- K881965MSI 5000 SERIES BED2Cleared 510(K)
- K881027MSI 2002 SERIES BED2Cleared 510(K)
- K875037STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED2Cleared 510(K)
- K873291MSI 9000 SERIES BED2Cleared 510(K)
- K872923PARAGON 9000 TILT AND TURN BED2Cleared 510(K)
- K872924PARAGON 8500 CARDIO-PULMONARY BED2Cleared 510(K)
- K872925MEGABED 10002Cleared 510(K)
- K864186HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT)2Cleared 510(K)
- K864172HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS2Cleared 510(K)
- K854937CARROM CARELIFE SERIES 40000 MODULAR BES SYSTEM2Cleared 510(K)
- K854867EVEREST & JENNINGS TRADITION-STANDARD BED L109684&2Cleared 510(K)
- K854832EVEREST & JENNING SERIES 5000 MODULAR BED2Cleared 510(K)
- K853270CENTERCOM CONTROL2Cleared 510(K)
- K852674STRYKER 988 ICU BED2Cleared 510(K)
- K851551MERIVAARA ELECTRIC HOSPITAL BED & ACCESSORIES2Cleared 510(K)
- K843781KINAIR, LOW AIR LOSS BED2Cleared 510(K)
- K831821PNEUMATIC/ELECTRIC/HYDRAULIC BED2Cleared 510(K)
- K830559HEALTHCARE MODEL #175/176 BED SERIES2Cleared 510(K)
- K821185NEW SUPPORT SYS. FOR BEDRIDDEN PATIENTS2Cleared 510(K)
- K811897LIC TURNOVER BED2Cleared 510(K)
- K790049BED, PARAPLEGIC2Cleared 510(K)
- K780371TILT TYPE AC POWERED HOSPITAL BED2Cleared 510(K)
- 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
SOMA SAFE ENCLOSURE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K963701
- 510(k) Type
- Traditional
- Applicant
- NOVA TECHNOLOGY CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/24/1997
- Days to Decision
- 130 days
- Submission Type
- Statement