Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- DZJDriver, Wire, And Bone Drill, Manual2Product Code
- DZKWire, Fixation, Intraosseous2Product Code
- DZLScrew, Fixation, Intraosseous2Product Code
- DZMNeedle, Dental1Product Code
- DZNInstruments, Dental Hand1Product Code
- DZPInstrument, Diamond, Dental1Product Code
- DYXLock, Wire, And Ligature, Intraoral2Product Code
- DZADrill, Dental, Intraoral1Product Code
- DZHSaw, Bone, Ac-Powered2Product Code
- DZIDrill, Bone, Powered2Product Code
- EAXMirror, Mouth1Product Code
- EAYLight, Fiber Optic, Dental1Product Code
- EAZLight, Operating, Dental1Product Code
- EBALight, Surgical Headlight1Product Code
- EBWController, Foot, Handpiece And Cord1Product Code
- ECBUnit, Syringe, Air And/Or Water1Product Code
- ECPInstrument, Ligature Tucking, Orthodontic1Product Code
- ECQAligner, Bracket, Orthodontic1Product Code
- ECRSetter, Band, Orthodontic1Product Code
- ECSPusher, Band, Orthodontic1Product Code
- ECTDriver, Band, Orthodontic1Product Code
- EFAHandpiece, Belt And/Or Gear Driven, Dental1Product Code
- EFBHandpiece, Air-Powered, Dental1Product Code
- EFKForceps, Articulation Paper1Product Code
- EFLForceps, Dressing, Dental1Product Code
- EGIParallelometer1Product Code
- EGMInjector, Jet, Mechanical-Powered2Product Code
- EGNScissors, Surgical Tissue, Dental1Product Code
- EGQInjector, Jet, Gas-Powered2Product Code
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental1Product Code
- EIBSyringe, Irrigating (Dental)1Product Code
- EICSyringe, Periodontic, Endodontic, Irrigating1Product Code
- EIDSyringe, Restorative And Impression Material1Product Code
- EIFAccessories, Retractor, Dental1Product Code
- EIGRetractor, All Types1Product Code
- EIKCarver, Wax, Dental1Product Code
- EILGauge, Depth, Instrument, Dental1Product Code
- EIRScissors, Collar And Crown1Product Code
- EISRemover, Crown1Product Code
- EIXProbe, Periodontic1Product Code
- EIYInstrument, Filling, Plastic, Dental1Product Code
- EJBHandle, Instrument, Dental1Product Code
- EJYPliers, Operative1Product Code
- EJZKnife, Margin Finishing, Operative1Product Code
- EKAFile, Margin Finishing, Operative1Product Code
- EKBExplorer, Operative1Product Code
- EKCExcavator, Dental, Operative1Product Code
- EKDInstrument, Cutting, Operative1Product Code
- EKECurette, Operative1Product Code
- EKFInstrument, Contouring, Matrix, Operative1Product Code
- EKGCondenser, Amalgam And Foil, Operative1Product Code
- EKHCarver, Dental Amalgam, Operative1Product Code
- EKICarrier, Amalgam, Operative1Product Code
- EKJBurnisher, Operative1Product Code
- EKKSpreader, Pulp Canal Filling Material, Endodontic1Product Code
- EKPReamer, Pulp Canal, Endodontic1Product Code
- EKQPreparer, Root Canal Endodontic1Product Code
- EKRPlugger, Root Canal, Endodontic1Product Code
- EKSFile, Pulp Canal, Endodontic1Product Code
- EKTCurette, Endodontic1Product Code
- EKWBroach, Endodontic1Product Code
- EKXHandpiece, Direct Drive, Ac-Powered1Product Code
- EKYHandpiece, Water-Powered1Product Code
- EKZUnit, Electrosurgical, And Accessories, Dental2Product Code
- ELAInstrument, Hand, Calculus Removal1Product Code
- ELBScaler, Rotary2Product Code
- ELCScaler, Ultrasonic2Product Code
- K242317Integrated Endo System (Meet Endo-II)2Cleared 510(K)
- K233844OdneClean2Cleared 510(K)
- K240707Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)2Cleared 510(K)
- K240801BioSonic US200 Ultrasonic Scaler (60034537)2Cleared 510(K)
- K233922SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG2Cleared 510(K)
- K223340EDS Calculus Softener TURBO CR2Cleared 510(K)
- K230641Ultrasonic Scaler Tips2Cleared 510(K)
- K223173Proxeo ULTRA (PB-510, PB-520 and PB-530)2Cleared 510(K)
- K231391Combi Touch2Cleared 510(K)
- K222096Endo Ultrasonic Activator2Cleared 510(K)
- K213947Ultrasonic Endo Activation Device (Model:Actor I pro)2Cleared 510(K)
- K210832EVOCLEAN CLEANsert Ultrasonic Insert2Cleared 510(K)
- K203615Dental Scaler and Air Polisher2Cleared 510(K)
- K202906EndoPilot22Cleared 510(K)
- K203302GentleWave X2Cleared 510(K)
- K201317TTBIO EVOCLEAN Ultrasonic Scaler2Cleared 510(K)
- K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One2Cleared 510(K)
- K191079Piezon Built-in Kit, Piezon Built-in Kit LED2Cleared 510(K)
- K182145tün® ultrasonic tips product family2Cleared 510(K)
- K190359Sonendo GentleWave System2Cleared 510(K)
- K171150AW-1002Cleared 510(K)
- K170104COMPACT S, COMPACT S (LED)2Cleared 510(K)
- K163414Ultrasonic scaler2Cleared 510(K)
- K161639Y-MIC2Cleared 510(K)
- K160905Sonendo GentleWave System2Cleared 510(K)
- K153157Sonendo Gentle Wave System2Cleared 510(K)
- K151023COMPACT PIEZO LED2Cleared 510(K)
- K150535Cavitron Touch Ultrasonic Scaling System2Cleared 510(K)
- K143448Sonendo GentleWave System2Cleared 510(K)
- K140233ULTRASONIC SCALER2Cleared 510(K)
- K140990EMS PIEZON 707 BIK AND PIEZON 707 BIK LED2Cleared 510(K)
- K140965MULTIPIEZO PRO, MULTIPIEZO2Cleared 510(K)
- K133752SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT2Cleared 510(K)
- K132322NEWTRON P5 XS B.LED2Cleared 510(K)
- K132267NEWTRON P5, NEWTRON P5 B.LED2Cleared 510(K)
- K132609EDS ULTRASONIC TIPS2Cleared 510(K)
- K131151ENDOCENTER2Cleared 510(K)
- K132445PIEZON 2502Cleared 510(K)
- K131997NEWTRON BOOSTER2Cleared 510(K)
- K132443PIEZON 1502Cleared 510(K)
- K130834R72Cleared 510(K)
- K130137BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER2Cleared 510(K)
- K130693AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM2Cleared 510(K)
- K130862CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM2Cleared 510(K)
- K130025SONENDO ENDOTHERAPY SYSTEM2Cleared 510(K)
- K122748ENGLER 25K SERIES ULTRASONIC INSERTS2Cleared 510(K)
- K122501AEI DR. TERAUCHI ULTRASONIC TIPS2Cleared 510(K)
- K123139ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES2Cleared 510(K)
- K113717ULTRASONIC SCALER2Cleared 510(K)
- K113530ULTRASONIC SCALER2Cleared 510(K)
- K113430PROULTRA PIEZO ULTRASONIC2Cleared 510(K)
- K110173EMS AIR-FLOW MASTER PIEZON2Cleared 510(K)
- K103498LAKONG ULTRASONIC SCALER2Cleared 510(K)
- K102218COMPACT PIEZO P2K, POWERCARE2Cleared 510(K)
- K093723EMS MINIMASTER LED2Cleared 510(K)
- K093000EMS PIEZON MASTER 7002Cleared 510(K)
- K100647A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM2Cleared 510(K)
- K100401SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM2Cleared 510(K)
- K092417INSIGHT ULTRASONIC INSERTS2Cleared 510(K)
- K081268SONIC AIR MM1500 + (MID), MODEL 504000142Cleared 510(K)
- K083059AIR SONIC SCALER2Cleared 510(K)
- K082973STER-MATE STERILE LAVAGE KIT2Cleared 510(K)
- K080089SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS2Cleared 510(K)
- K081550BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO2Cleared 510(K)
- K071447VARIOS 752Cleared 510(K)
- K072107PERIOSCAN, MODEL: D 34962Cleared 510(K)
- K071981BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)2Cleared 510(K)
- K071424PMAX NEWTRON XS2Cleared 510(K)
- K070975SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES2Cleared 510(K)
- K070307STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT2Cleared 510(K)
- K062731ULTRASONIC SCALER, VARIOS 5602Cleared 510(K)
- K070866ASC-12 PIEZOELECTRIC SCALER2Cleared 510(K)
- K062791USI DENTAL SCALER, 25XXX SERIES2Cleared 510(K)
- K053555ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L2Cleared 510(K)
- K061448BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES2Cleared 510(K)
- K053578SCORPION ULTRASONIC SCALING INSERTS2Cleared 510(K)
- K060275PIEZOTOME2Cleared 510(K)
- K060171CLEANSE S+ ULTRASONIC SCALER2Cleared 510(K)
- K053178SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS2Cleared 510(K)
- K052518PIEZOSURGERY2Cleared 510(K)
- K053030J. MORITA AZ ULTRASONIC SYSTEM2Cleared 510(K)
- K052028BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)2Cleared 510(K)
- K052334CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-1312Cleared 510(K)
- K051910MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER2Cleared 510(K)
- K051547POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM302Cleared 510(K)
- K051776PROTEGE ULTRASONIC INSERT2Cleared 510(K)
- K050895SURPASSON P5 NEWTRON2Cleared 510(K)
- K050710MINIMASTER ULTRASONIC SCALER2Cleared 510(K)
- K050354PERIOSCAN ULTRASONIC SCALER2Cleared 510(K)
- K042972XP TECHNOLOGY ULTRASONIC SCALER2Cleared 510(K)
- K033044DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER2Cleared 510(K)
- K042056AZ ULTRASONIC SYSTEM2Cleared 510(K)
- K033198APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U22Cleared 510(K)
- K040396ULTRASONIC SCALER ELEGANCE MS-10 (25K)2Cleared 510(K)
- K031421ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)2Cleared 510(K)
- K033764SP NEWTRON MODULE2Cleared 510(K)
- K033120SCALETRON PIEZO ULTRASOUND SCALER2Cleared 510(K)
- K033640SIROSON L AND SIROSONIC L ULTRASONIC SCALERS2Cleared 510(K)
- K033705BOBCAT PRO SCALER SYSTEM, MODEL G-1302Cleared 510(K)
- K032995SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)2Cleared 510(K)
- K031461CARRIER TIPS2Cleared 510(K)
- K030111DIAMONDCOAT ULTRASONIC INSERTS2Cleared 510(K)
- K023697STERI-MATE STERILIZABLE HANDPIECE2Cleared 510(K)
- K022328EMS PIEZON MASTER 6002Cleared 510(K)
- K021253ULTRASONIC TIPS WITH DIAMOND COATING2Cleared 510(K)
- K014238DELSONIC 20002Cleared 510(K)
- K012060MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT2Cleared 510(K)
- K011179DELDENT ULTRASONIC INSERTS2Cleared 510(K)
- K010195PREMIER ULTRASONIC SCALER AND INSERTS2Cleared 510(K)
- K002122VECTOR2Cleared 510(K)
- K002753SPARTAN A-102Cleared 510(K)
- K000846TKD SCALERS2Cleared 510(K)
- K002521SPARTAN MTS2Cleared 510(K)
- K000510ART-M1, MODEL M1-1-ART-A12Cleared 510(K)
- K994299ART-P3, MODEL P3-1-ART-A12Cleared 510(K)
- K994203ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A12Cleared 510(K)
- K992504EMS KERMIT2Cleared 510(K)
- K990546DELSONIC 20002Cleared 510(K)
- K991239VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-22Cleared 510(K)
- K991874EMS SURFACE MOUNT SCALER2Cleared 510(K)
- K991021SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL2Cleared 510(K)
- K983029POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S10012Cleared 510(K)
- K983727BIOSONIC ULTRASONIC SCALER SYSTEM2Cleared 510(K)
- K982793PIEZO TRONIC2Cleared 510(K)
- K972026SP4044 & SP4055 LUX MODULES2Cleared 510(K)
- K964596PROSELECT 3 PERIDONTAL THERAPY SYSTEM2Cleared 510(K)
- K970123DENTSPLY CAVITRON SPS SCALER SYSTEM2Cleared 510(K)
- K970342CAVITRON JET WITH SPS SYSTEM2Cleared 510(K)
- K964320TONY RISO 25/30 MULTIFUNCTION SCALER2Cleared 510(K)
- K961158SUPRASSON P5 BOOSTER2Cleared 510(K)
- K960889SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS2Cleared 510(K)
- K943403CONDOR ULTRASONIC INSERTS2Cleared 510(K)
- K954820SCALEX 8002Cleared 510(K)
- K953919DENTAL ULTRASONIC SCALER INSERTS2Cleared 510(K)
- K942139SUPRASSON P MAX2Cleared 510(K)
- K953026MINIPIEZON2Cleared 510(K)
- K942380MICRO ICS SONIC SCALER2Cleared 510(K)
- K951272RELACS 70002Cleared 510(K)
- K950256TURBO 25/302Cleared 510(K)
- K950240LE CLEAN MACHINE2Cleared 510(K)
- K941392JET UNIT (CJ HANDPIECE)2Cleared 510(K)
- K934714ENDODONTIC PULP CANAL SPREADER2Cleared 510(K)
- K933547INTRA-ORAL IRRIGATOR2Cleared 510(K)
- K920328AMDENT 2030, POLISHER/SCALER2Cleared 510(K)
- K930698THE MODEL 3003 SCALER2Cleared 510(K)
- K921893COLGATE ODONTOSON ULTRASONIC SCALER2Cleared 510(K)
- K923639DIAMOND COATED DENTAL INSERTS2Cleared 510(K)
- K903298DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP2Cleared 510(K)
- K904296LYSTA HYGIENIST III SCALER2Cleared 510(K)
- K903163PERIODONTAL DEBRIDING SOLUTION E2Cleared 510(K)
- K896749PIEZON MASTER 4002Cleared 510(K)
- K902413SONIC SCALER2Cleared 510(K)
- K901488LYNX-SM, SCLAER DENTAL HANDPIECE2Cleared 510(K)
- K900709AIR FLOW SII2Cleared 510(K)
- K894247PERIODONTAL IRRIGATING SOLUTION-D2Cleared 510(K)
- K884221ULTRASONIC SCALER COVER2Cleared 510(K)
- K880940AMDENT MODEL 830 ULTRASONIC SCALER2Cleared 510(K)
- K881253ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW2Cleared 510(K)
- K873146USI BASIC. AG 1050. AG 10902Cleared 510(K)
- K864996ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 302Cleared 510(K)
- K863676GENTEEL2Cleared 510(K)
- K853841HARMO SONIC2Cleared 510(K)
- K852525SATALEC PIEZOTEC2Cleared 510(K)
- K852540ULTRASONIC TOOTH SCALER MODEL DSCIOP2Cleared 510(K)
- K844250OSADA ENAC2Cleared 510(K)
- K842581CAVI-MED2Cleared 510(K)
- K840141DENTAL ULTRASONIC SCALER/ENDOSONIC2Cleared 510(K)
- K834283DENTSPLY G-106 CAVITRON ULTRASONIC2Cleared 510(K)
- K832664SATELEC SUPRASSON PIEZOMATIC P22Cleared 510(K)
- K832674SATELEC PROPHY UNIT PU 2000S2Cleared 510(K)
- K832665SATELEC SUPRASSON SP 30552Cleared 510(K)
- K832443ULTRASONIC DENTAL PROPHYLAXIS UNIT2Cleared 510(K)
- K823134AIR FLOW II2Cleared 510(K)
- K821810PIEZON ULTRASONIC SCALER2Cleared 510(K)
- K820162TEC-SON II2Cleared 510(K)
- K812909HYGIENTIST; CYCLOSON I & II; RETROFIT2Cleared 510(K)
- K811396SONUS V2Cleared 510(K)
- K811145PNEUMATIC DENTAL SCALER2Cleared 510(K)
- K811023ROOT CANAL KIT2Cleared 510(K)
- K801689SONATRON ULTRASONIC DENTAL SCANNER2Cleared 510(K)
- K791704MASTERSCALE II2Cleared 510(K)
- K791585MODEL G-61 ULTRASONIC DENTAL UNIT2Cleared 510(K)
- K791024ULTRASONIC DENTAL PROPHYLAXIS UNIT2Cleared 510(K)
- K782133ODONTOSON 32Cleared 510(K)
- K781044ULTRASONIC DENTAL PROPHYLAXIS UNIT,SSM2Cleared 510(K)
- K780808PIEZOMATIC ULTRASONIC SCALER (SYSTEM S)2Cleared 510(K)
- K771556EXR2Cleared 510(K)
- K771557ULTRASON 9902Cleared 510(K)
- K761246SONUS III2Cleared 510(K)
- K761247LT:200, LOVING TOUCH2Cleared 510(K)
- K760805ULTRASONIC DENTAL PROPHYLAXIS DEVICE2Cleared 510(K)
- K760445DENTAL PROPHYLAXIS UNIT ULTRASONIC2Cleared 510(K)
- EMDHemostat, Surgical1Product Code
- EMEPunch, Biopsy, Surgical1Product Code
- EMGForceps, Tooth Extractor, Surgical1Product Code
- EMHForceps, Rongeur, Surgical1Product Code
- EMIFile, Bone, Surgical1Product Code
- EMJElevator, Surgical, Dental1Product Code
- EMKCurette, Surgical, Dental1Product Code
- EMLChisel, Bone, Surgical1Product Code
- EMMChisel, Osteotome, Surgical1Product Code
- EMNScaler, Periodontic1Product Code
- EMOKnife, Periodontic1Product Code
- EMPMarker, Periodontic1Product Code
- EMQHoe, Periodontic1Product Code
- EMRFile, Periodontic1Product Code
- EMSCurette, Periodontic1Product Code
- JEPRetainer, Matrix1Product Code
- JEXPlier, Orthodontic1Product Code
- JEYPlate, Bone2Product Code
- KMWHandpiece, Rotary Bone Cutting2Product Code
- MDLImplant, Transmandibular2Product Code
- MQNExternal Mandibular Fixator And/Or Distractor2Product Code
- MXFSystem, Dental, Hydrokinetic, Caries Removal & Cavity Preparation2Product Code
- NEIProsthesis, Condyle, Mandibular, Temporary2Product Code
- NLDInstrument, Diamond, Dental, Reprocessed1Product Code
- NMWNeedle, Dental, Reprocessed1Product Code
- NYCDental Prophylaxis Kit1Product Code
- NYFGingival Retraction Kit1Product Code
- NYGLapping Tool Kit1Product Code
- NYLHandpiece, Air-Powered, Root Canal Irrigation1Product Code
- PLVDental Stereotaxic Instrument2Product Code
- PWLOral Surgery Tray1Product Code
- NVKLaser, Dental, Soft Tissue2Product Code
- OAJCatheter, Drainage, Intraoral/Extraoral1Product Code
- PEMDental Barriers And Sleeves2Product Code
- QRYDental Navigation System2Product Code
- 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
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- 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
Piezon Built-in Kit, Piezon Built-in Kit LED
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K191079
- 510(k) Type
- Traditional
- Applicant
- E.M.S Electro Medical Systems S.A
- Country
- Switzerland
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/16/2019
- Days to Decision
- 115 days
- Submission Type
- Summary