Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- DSMAlarm, Leakage Current, Portable1Product Code
- DPSElectrocardiograph2Product Code
- DPTProbe, Blood-Flow, Extravascular2Product Code
- DPWFlowmeter, Blood, Cardiovascular2Product Code
- DQBPhlebograph, Impedance2Product Code
- DQCPhonocardiograph1Product Code
- DQHCardiograph, Apex (Vibrocardiograph)2Product Code
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency2Product Code
- DRIMonitor, Line Isolation1Product Code
- DRJSystem, Signal Isolation1Product Code
- DRQAmplifier And Signal Conditioner, Transducer Signal2Product Code
- DRRAmplifier And Signal Conditioner, Biopotential2Product Code
- DRSTransducer, Blood-Pressure, Extravascular2Product Code
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)2Product Code
- DRWAdaptor, Lead Switching, Electrocardiograph2Product Code
- DRXElectrode, Electrocardiograph2Product Code
- K171244Physiotrace2Cleared 510(K)
- K140096HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE2Cleared 510(K)
- K123658BIOMODULE 3-M12Cleared 510(K)
- K101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES2Cleared 510(K)
- K101685IP-SET2Cleared 510(K)
- K100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X2Cleared 510(K)
- K093327INTCO TAB ELECTRODE2Cleared 510(K)
- K10031512 LEAD GLOVE2Cleared 510(K)
- K092744NEONATAL ECG ELECTRODE, M203KEN2Cleared 510(K)
- K092389DISPOSAL ECG ELECTRODES, MODEL EASYRODE2Cleared 510(K)
- K090496QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH2Cleared 510(K)
- K092291SKINTACT AND VARIOUS OTHER TRADENAMES2Cleared 510(K)
- K091856CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES2Cleared 510(K)
- K090180TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE2Cleared 510(K)
- K083677PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES12Cleared 510(K)
- K083148TELECTRODE WET GEL ECG ELECTRODE2Cleared 510(K)
- K080602AUDICOR SENSOR, MODELS: 2.0, 3.02Cleared 510(K)
- K080106SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE2Cleared 510(K)
- K073104SKINTACT AND VARIOUS OTHER TRADENAMES2Cleared 510(K)
- K071576TEXTRONICS ECG ELECTRODE2Cleared 510(K)
- K063044CARDIOBELT ELECTRODE BELT2Cleared 510(K)
- K062760ORI F6T DRY ECG MONITORING ELECTRODE2Cleared 510(K)
- K053550AMBU BLUE SENSOR NEO AND NEO X2Cleared 510(K)
- K052944AMBU WHITE SENSOR CFM, CFL2Cleared 510(K)
- K060661MACTRODE 32Cleared 510(K)
- K053011PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR202Cleared 510(K)
- K050443ACCU-LEAD2Cleared 510(K)
- K050248ELECTRODE2Cleared 510(K)
- K043361ACCUHEART ELECTRODE BELT2Cleared 510(K)
- K03355912-LEAD GLOVE2Cleared 510(K)
- K041734AMBU DISPOSABLE ECG ELECTRODE2Cleared 510(K)
- K041954DISPOSABLE MONITORING ELECTRODES2Cleared 510(K)
- K041026AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S2Cleared 510(K)
- K040784PROTAB ECG TABB ELECTRODE2Cleared 510(K)
- K040249SKINTACT ECG ELECTRODE2Cleared 510(K)
- K030316AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)2Cleared 510(K)
- K031174BODY SIGNAL ECG ELECTRODE2Cleared 510(K)
- K030073VERMED A10021 RESTING EKG TAB ELECTRODE2Cleared 510(K)
- K030509SKINTACT ECG TAB ELECTRODE2Cleared 510(K)
- K024247SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL2Cleared 510(K)
- K024264SKINTACT2Cleared 510(K)
- K023920SKINTACT2Cleared 510(K)
- K022909NIKOMED TRACE 1 ECG ELECTRODES2Cleared 510(K)
- K023503SKINTACT ECG ELECTRODE2Cleared 510(K)
- K020003ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE2Cleared 510(K)
- K020382BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA2Cleared 510(K)
- K011564NEOLEAD2Cleared 510(K)
- K003804SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,408012Cleared 510(K)
- K002230CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-0022Cleared 510(K)
- K993934V QUICK PATCH2Cleared 510(K)
- K0006903M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE2Cleared 510(K)
- K000206PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN2002Cleared 510(K)
- K990110DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 41402Cleared 510(K)
- K990115DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 44402Cleared 510(K)
- K990113DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 45602Cleared 510(K)
- K990112DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 46102Cleared 510(K)
- K990111DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 45702Cleared 510(K)
- K991105ECG ELECTRODE (VARIOUS)2Cleared 510(K)
- K982521SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES2Cleared 510(K)
- K983689BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES2Cleared 510(K)
- K981964MEDI-TRACE 4103 NEONATAL ELECTRODE2Cleared 510(K)
- K982470ECG ELECTRODES APRON2Cleared 510(K)
- K9744453M RED DOT RESTING EKG ELECTRODE, CATALOG 23602Cleared 510(K)
- K973663PALJET-B2Cleared 510(K)
- K973727ELECTRODE, ELECTROCARDIOGRAPH2Cleared 510(K)
- K972001NICAS(TM) ELECTRODE2Cleared 510(K)
- K9714443M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES2Cleared 510(K)
- K970755STEALTHSHIELD2Cleared 510(K)
- K9707963M RED DOT 2560 & 2570 MONITORING ELECTRODES2Cleared 510(K)
- K963787EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM2Cleared 510(K)
- K970125NOAH MONITORING ELECTRODE SYSTEM2Cleared 510(K)
- K963975VERSATEC 310 ELECTRODE2Cleared 510(K)
- K963159CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES2Cleared 510(K)
- K961643MEDICOTEST ECG ELECTRODES2Cleared 510(K)
- K964213TRACE RITE SOLID GEL ECG ELECTRODES2Cleared 510(K)
- K963151MEDI-TRACE 5700 RESTING ECG ELECTRODE2Cleared 510(K)
- K963038MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE2Cleared 510(K)
- K960968MEDI-TRACE 200, MEDI-TRACE 200-302Cleared 510(K)
- K962115CAMBRIDGE HEART HI-RES ECG ELECTRODE2Cleared 510(K)
- K961288BODYTRODE2Cleared 510(K)
- K962122SENTRY RADIOTRANSLUCENT ECG ELECTRODES2Cleared 510(K)
- K955815G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE2Cleared 510(K)
- K960721PACEART WRIST ELECTRODES2Cleared 510(K)
- K954773QUICKELS QS 100 SYSTEM2Cleared 510(K)
- K954772QUICKELS QS 200 SYSTEM2Cleared 510(K)
- K953649DISPOSABLE ECG ELECTRODE2Cleared 510(K)
- K961395MEDI-TRACE RADIOLUCENT2Cleared 510(K)
- K955800SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODE2Cleared 510(K)
- K944497UNILECT, MONITAB AND BIOTRACE-HR2Cleared 510(K)
- K954389CONMED ECG/EKG ELECTRODES2Cleared 510(K)
- K944496BIOTRACE-N, NS, 410 AND RT2Cleared 510(K)
- K960264CONMED EKG STRIPPER2Cleared 510(K)
- K954388CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE2Cleared 510(K)
- K950473DISPOSABLE ECG MONITORING ELECTRODE2Cleared 510(K)
- K950475DISPOSABLE ECG MONITORING ELECTRODE #4530, #45402Cleared 510(K)
- K950472DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM2Cleared 510(K)
- K950474DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM2Cleared 510(K)
- K950480DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM2Cleared 510(K)
- K950478DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM2Cleared 510(K)
- K950477DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM2Cleared 510(K)
- K950471DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM2Cleared 510(K)
- K950470DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM2Cleared 510(K)
- K950587ECOTABS2Cleared 510(K)
- K950479DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM2Cleared 510(K)
- K950476DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM2Cleared 510(K)
- K950485GRAPHIC CONTROLS PROTRACE ECG ELECTRODE2Cleared 510(K)
- K945479MEDI-TRACE(R) 500 ECG ELECTRODE2Cleared 510(K)
- K944260ECG ELECTRODE2Cleared 510(K)
- K950488GRAPHIC CONTROLS BIOTAC ECO ELECTRODE2Cleared 510(K)
- K950489GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE2Cleared 510(K)
- K9458361800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES2Cleared 510(K)
- K950486GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE2Cleared 510(K)
- K950487GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE2Cleared 510(K)
- K9462731700 MONITORING ECG ELECTRODE2Cleared 510(K)
- K935437ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES2Cleared 510(K)
- K932903EKG VEST2Cleared 510(K)
- K943301QUIK COMBO2Cleared 510(K)
- K935371R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD2Cleared 510(K)
- K9447261710 MONITORING ECG ELECTRODE2Cleared 510(K)
- K944655ECG ELECTRODE2Cleared 510(K)
- K934505TRIGEL MULTIFUNCTION ELECTRODE2Cleared 510(K)
- K935246ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES2Cleared 510(K)
- K945214MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE2Cleared 510(K)
- K935429ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES2Cleared 510(K)
- K9448492700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE2Cleared 510(K)
- K941977TAYLOR LONG TERM MONITORING ELECTRODE2Cleared 510(K)
- K935281ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES2Cleared 510(K)
- K934000SENTRY AQUEOUS GEL ECG ELECTRODES2Cleared 510(K)
- K940801K-KLIP2Cleared 510(K)
- K942925CONMED ANDOVER MED ECG ELECTRODES2Cleared 510(K)
- K9343333M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE2Cleared 510(K)
- K940802ZIPPREP ELECTRODE2Cleared 510(K)
- K940586K-SNAP2Cleared 510(K)
- K931457NDM SILVON ECG ELECTRODES2Cleared 510(K)
- K931903SURELOCK(TM) SNAPLESS MONITORING ELECTRODE2Cleared 510(K)
- K9303123M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE2Cleared 510(K)
- K9324543M RED DOT 2330 RESTING EKG ELECTRODE2Cleared 510(K)
- K930258TRACET T-60002Cleared 510(K)
- K921164MODEL 1300 SOFTRACE II ELECTRODE2Cleared 510(K)
- K923558ECG ELECTRODE2Cleared 510(K)
- K911529BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG2Cleared 510(K)
- K911518BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM2Cleared 510(K)
- K924133ELECTROTRACE, MODIFICATION2Cleared 510(K)
- K921207DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION2Cleared 510(K)
- K921579BR-50-J DISPOSABLE ECG ELECTRODE2Cleared 510(K)
- K920867EME MP3000 MONITORING AND DIAGNOSTIC RESTING ECG2Cleared 510(K)
- K914672QR-50-E DISPOSABLE RADIOTRANSLUCENT ECG ELECTRODE2Cleared 510(K)
- K911687VER-MED A10020 RESTING EKG ELECTRODE2Cleared 510(K)
- K911472BIO-SENSOR 01 EKG ELECTRODE2Cleared 510(K)
- K913226MODEL #810 STEALTH-STIM ADULT STIMULATION PADS2Cleared 510(K)
- K912450TRACETS SME 50002Cleared 510(K)
- K910139VER-MED A10014 RESTING EKG ELECTRODE & A100212Cleared 510(K)
- K912714RT40 RADIO TRANSLUCENT2Cleared 510(K)
- K911990ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.2Cleared 510(K)
- K910494RESTING EKG ELECTRODE SERIES2Cleared 510(K)
- K905489VER-MED A10017 UNIVERSAL ELECTRODE2Cleared 510(K)
- K905729CANMED 4512Cleared 510(K)
- K905446MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE2Cleared 510(K)
- K904512TRACET AG 40002Cleared 510(K)
- K903491MONITRODE2Cleared 510(K)
- K903555ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC.2Cleared 510(K)
- K904185SENSATRACE2Cleared 510(K)
- K903918MODEL 1850 ELECTRODE2Cleared 510(K)
- K902738ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH2Cleared 510(K)
- K902176SILVER MACTRODE2Cleared 510(K)
- K902407NF-50-E DISPOSABLE ECG ELECTRODE2Cleared 510(K)
- K902080RED DOT 2269 INFANT MONITORING ELECTRODE2Cleared 510(K)
- K901555MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE2Cleared 510(K)
- K900519CLASSIC ECG/STIMULATING NO. 1700 SERIES2Cleared 510(K)
- K896569ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC.2Cleared 510(K)
- K896155RED DOT CARDIAC SENSOR SYSTEM2Cleared 510(K)
- K895834BABY MAC ELECTROCARDIOGRAPH ELECTRODE2Cleared 510(K)
- K894991ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO.2Cleared 510(K)
- K894462CARE DISP. DIAG. ELECTRODES, SILVER/SILVER2Cleared 510(K)
- K894920SELECTRODE2Cleared 510(K)
- K894679ELECTROTRACE DISP. RESTING EKG ELECTRODES2Cleared 510(K)
- K894648ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO2Cleared 510(K)
- K894562ARBO H79P DISPOSABLE MONITORING ELECTRODES2Cleared 510(K)
- K893425VITATRACE2Cleared 510(K)
- K893245L30-LB- INFANT LIMB BAND2Cleared 510(K)
- K884980F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM2Cleared 510(K)
- K891075BARD NEONATAL ECG MONITORING ELECTRODE2Cleared 510(K)
- K890201RADIOLUCENT ECG ELECTRODE MODEL NO: 16802Cleared 510(K)
- K884981F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM2Cleared 510(K)
- K884982M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,682Cleared 510(K)
- K884983M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 552Cleared 510(K)
- K884984M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 402Cleared 510(K)
- K885306NUPREP2Cleared 510(K)
- K884775ARBO PINK H82P2Cleared 510(K)
- K885262POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES2Cleared 510(K)
- K890103BARD TAB ECG MONITORING ELECTRODE2Cleared 510(K)
- K883643TDK ECG ELECTRODE, MEL-10L2Cleared 510(K)
- K884064BARD MULTI-TAC ECG MONITORING ELECTRODE2Cleared 510(K)
- K882904TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-52Cleared 510(K)
- K882216SYNCOR (R) MODEL S-801 ECG ELECTRODE2Cleared 510(K)
- K881085SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE2Cleared 510(K)
- K875015TRACETS 30002Cleared 510(K)
- K875041FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE2Cleared 510(K)
- K874562SECURATRODE2Cleared 510(K)
- K874423PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E2Cleared 510(K)
- K874421PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A2Cleared 510(K)
- K874424PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E2Cleared 510(K)
- K874422PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D2Cleared 510(K)
- K872866STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE)2Cleared 510(K)
- K874437TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE)2Cleared 510(K)
- K873682FERRIS ECG ELECTRODE W/HYDROGEL2Cleared 510(K)
- K874628RESUBMITTED STANDARD MICROPORE ECG ELECTRODE2Cleared 510(K)
- K873442ECG ELECTRODE SYSTEM2Cleared 510(K)
- K872871NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)2Cleared 510(K)
- K872784MACTRODE-II2Cleared 510(K)
- K871441ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE2Cleared 510(K)
- K871748THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE2Cleared 510(K)
- K871668BIODAN TYPE COMET ELECTRODE2Cleared 510(K)
- K871325BOWEN REUSEABLE/DISPOSABLE ELECTRODE2Cleared 510(K)
- K871626ELECTROTRACE DISP REST EKG ELECTRODE, CAT. ET12002Cleared 510(K)
- K871412CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO2Cleared 510(K)
- K864260APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)2Cleared 510(K)
- K864690ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD2Cleared 510(K)
- K870873MD MONITORING/DIAGNOSTIC ELECTRODE2Cleared 510(K)
- K870834TDK ECG ELECTRODE MEL-102Cleared 510(K)
- K865011PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER2Cleared 510(K)
- K864586S&W ELECTRODE TYPES 888, 844, 988 AND 9442Cleared 510(K)
- K863674TRACETS 2000/ELECTRODES2Cleared 510(K)
- K864722MEDI-TRACE INFANT ELECTRODE2Cleared 510(K)
- K864868MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK2Cleared 510(K)
- K863904DISPOSABLE ECG MONITORING ELECTRODE2Cleared 510(K)
- K863369MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES2Cleared 510(K)
- K863584EM II STRESS TEST ELECTRODE2Cleared 510(K)
- K863540EM II DISPOSABLE ELECTRODE2Cleared 510(K)
- K863366PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE2Cleared 510(K)
- K863845EM III DISPOSABLE ELECTRODE2Cleared 510(K)
- K862618SKINTACT AG ELECTRODES2Cleared 510(K)
- K862765EUROMED S-6012Cleared 510(K)
- K862746EM DIAGNOSTIC ECG ELECTRODE2Cleared 510(K)
- K862655SIGNA II RESTING ECG ELECTRODE2Cleared 510(K)
- K861246PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD2Cleared 510(K)
- K861099GEREONICS BIOPOTENTIAL SKIN ELECTRODES2Cleared 510(K)
- K861158S&W TYPE 888 ELECTRODE2Cleared 510(K)
- K860827EM STRESS ELECTRODE2Cleared 510(K)
- K854433ECG MONITORING/DEFIBRILLATION ELECTRODE2Cleared 510(K)
- K8547575000 SERIES ECG ELECTRODES2Cleared 510(K)
- K853774EM ELECTRODE2Cleared 510(K)
- K853939ECG-ELECTRODE(SWAROMED)2Cleared 510(K)
- K853993DOBE (MODIFIED)2Cleared 510(K)
- K853705BOMED-EEA2Cleared 510(K)
- K853038DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES2Cleared 510(K)
- K851522DIAGNOSTIC ECG DISPOSABLE ELECTRODE2Cleared 510(K)
- K852469SAF-D-FIB2Cleared 510(K)
- K851732CARBOCONE2Cleared 510(K)
- K852177FOAM ECG ELECTRODES2Cleared 510(K)
- K840445SYNKARA2Cleared 510(K)
- K850130PRN ECG ELECTRODE2Cleared 510(K)
- K850132DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC2Cleared 510(K)
- K842514ELECTROCARDIOGRAM DISPOS. ELECTRODE PAD2Cleared 510(K)
- K841944DISPOSABLE ECG ELECTRODE2Cleared 510(K)
- K850085DISPOSABLE ECG ELECTRODES EASATRACE2Cleared 510(K)
- K844856ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON2Cleared 510(K)
- K844632INFANT LIMB ELECTRODE2Cleared 510(K)
- K844345CONTOUR ELECTRODE2Cleared 510(K)
- K844335ELECTROCARDIOGRAPH ELECTRODE2Cleared 510(K)
- K844100CANMED 1012Cleared 510(K)
- K844099CANMED 1022Cleared 510(K)
- K840646CARDIOTRODE2Cleared 510(K)
- K840465Q-MED ELECTRODE2Cleared 510(K)
- K832903ESOPHOGRAL MULTIPROBE2Cleared 510(K)
- K832429CARDIO TRACE ELECTRODE2Cleared 510(K)
- K834445MEDI-TRACE QUIKSET DX DIAG. ELECT-2Cleared 510(K)
- K833899TDK ECG ELECTRODE MEL-082Cleared 510(K)
- K833695ADULT MONITORING ELECTOR@@RODE 9431-3002Cleared 510(K)
- K832877PRE-GELLED DISPOS ELECTRODE2Cleared 510(K)
- K832516MAGNATRODE CARDIAC MONITORING ELECTRODE2Cleared 510(K)
- K831977C TEC SERIES 9000 E.C.G. ELECTRODE2Cleared 510(K)
- K830655QUIK-SILVER RESTING ECG ELECTRODE2Cleared 510(K)
- K830362INFANT ELECTRODE BELT2Cleared 510(K)
- K830663PENCIL SKIN ABRADER2Cleared 510(K)
- K822750MEDI-TRACE 5' OFFSET ELECTRODE2Cleared 510(K)
- K822798DISPOSABLE ELECTRODE #19002Cleared 510(K)
- K821846LDS MONITORING ELECTRODE2Cleared 510(K)
- K821802CENTURION ELECTRODE BELT2Cleared 510(K)
- K821434EKG (ECG) ELECTRODES2Cleared 510(K)
- K821535VITALINE DISPOSABLE EKG ELECTRODE-LEAD2Cleared 510(K)
- K821757QUIK - PREP2 ELECTRODE2Cleared 510(K)
- K821506MEDICOTEST ECG ELECTRODES2Cleared 510(K)
- K821438RED DOT MONITORING ELECTRODES #2260/652Cleared 510(K)
- K821137MEDITRACE PELLET ELECTRODE2Cleared 510(K)
- K820122PIONEER II BACK PLATE ELECTRODE2Cleared 510(K)
- K813176GEL ELECTRODE2Cleared 510(K)
- K813013GEL ELECTRODE2Cleared 510(K)
- K812878THE NEW 1600 ELECTRODE2Cleared 510(K)
- K812276DISPOSABLE ELECTRODE, #16102Cleared 510(K)
- K810895ESOPHAGEAL PILL ELECTRODE2Cleared 510(K)
- K810563QUINTON LTE ELECTRODE2Cleared 510(K)
- K803179DISPOSABLE ELECTRODE FOR EKG2Cleared 510(K)
- K810102INFANT ECG ELECTRODE #60-10292Cleared 510(K)
- K810103ADULT ECG ELECTRODE #60-07242Cleared 510(K)
- K802576EXTERNAL JUGULAR CVP CATHERIZATION KIT2Cleared 510(K)
- K801846ELECTROCARDIOGRAPH ELECTRODE2Cleared 510(K)
- K800930R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.2Cleared 510(K)
- K800935R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS)2Cleared 510(K)
- K800201ESOPHAGEAL PILL-ELECTRODE2Cleared 510(K)
- K792436VXTRA BACK PACK EKG ELECTRODE CAT. NO.2Cleared 510(K)
- K792040BARD BIOMEDICAL PRINTED SILVER ELECTRODE2Cleared 510(K)
- K791140PREGELLED DISPOSABLE EELCTRO. SERIES 6002Cleared 510(K)
- K791139PREGELLED DISPOSABLE ECG ELECTRODES2Cleared 510(K)
- K791006SMART BILECTRODES2Cleared 510(K)
- K791002ECG ELECTRODES, PEDIATRIC-FOAM TAPE2Cleared 510(K)
- K791003ECG ELECTRODES, PEDIATRIC-MICROPOROUS TA2Cleared 510(K)
- K790959LIFEPATCH ECG ELECTRODES2Cleared 510(K)
- K790507800 ECG ELECTRODE2Cleared 510(K)
- K790730NDM PAPER TAPE ECG ELECTRODE2Cleared 510(K)
- K790305ELECTRODES, FERRIS ECG, TYPES 905,9062Cleared 510(K)
- K782079ELECTRODE SYSTEM, QUIK-PREP2Cleared 510(K)
- K781963ELECTRODES, OFFSET AND DX2Cleared 510(K)
- K781940EKG ELECTRODES, DISPOSABLE2Cleared 510(K)
- K781430PREGELLED DISPOSABLE E.K.G. ELECTRODE2Cleared 510(K)
- K781514ECG ELECTRODE, 2021, 2022, 2032, 20332Cleared 510(K)
- K781518PREGELLED DISPOSABLE ELECTRODE2Cleared 510(K)
- K781163ELECTRODE, DEIP.2Cleared 510(K)
- K780908SELF-RETAINING ELECTRODE SER. #4000-1002Cleared 510(K)
- K771776ECG CLUSTER ELECTRODE2Cleared 510(K)
- K771392ACCU-TRODE (DISP. ECG ELECTRODE)2Cleared 510(K)
- K771447PREGELLED DISP. EKG MONITORING ELECT-2Cleared 510(K)
- K770988FOAM ECG ELECTRODE, 2060 AND 20612Cleared 510(K)
- K770521ELECTROCARDIOGRAPHIC ELECTRODES, DISP.2Cleared 510(K)
- K770083LIFEPATCH TM ECG ELECTRODE2Cleared 510(K)
- K761301V-TRACE ECG BACKPAD2Cleared 510(K)
- K761249RADIO TRANSPARENT ECG ELECTRODE2Cleared 510(K)
- K760358ELECTRODE SERIES 16002Cleared 510(K)
- K760280ELECTRODE SERIES 14012Cleared 510(K)
- DRZOscillometer2Product Code
- DSACable, Transducer And Electrode, Patient, (Including Connector)2Product Code
- DSBPlethysmograph, Impedance2Product Code
- DSFRecorder, Paper Chart1Product Code
- DSHRecorder, Magnetic Tape, Medical2Product Code
- DXHTransmitters And Receivers, Electrocardiograph, Telephone2Product Code
- DXJDisplay, Cathode-Ray Tube, Medical2Product Code
- DXKEchocardiograph2Product Code
- DXOTransducer, Pressure, Catheter Tip2Product Code
- DXPTransducer, Vessel Occlusion2Product Code
- DXRBallistocardiograph2Product Code
- DYCVectorcardiograph2Product Code
- JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic2Product Code
- JONTransducer, Apex Cardiographic2Product Code
- JOOTransducer, Heart Sound2Product Code
- JOPTransducer, Ultrasonic2Product Code
- KRCTester, Electrode, Surface, Electrocardiographic2Product Code
- MLCMonitor, St Segment2Product Code
- MLNElectrode, Electrocardiograph, Multi-Function2Product Code
- MLOElectrocardiograph, Ambulatory, With Analysis Algorithm2Product Code
- MSXSystem, Network And Communication, Physiological Monitors2Product Code
- MUDOximeter, Tissue Saturation2Product Code
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2Product Code
- MWJElectrocardiograph, Ambulatory (Without Analysis)2Product Code
- MXCRecorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)2Product Code
- NMDOximeter, Tissue Saturation, Reprocessed2Product Code
- NQHSensor, Pressure, Aneurysm, Implantable2Product Code
- OCHOximeter, Infrared, Sporting, Aviation2Product Code
- OEYSingle Lead Over-The-Counter Electrocardiograph2Product Code
- QMESoftware For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate2Product Code
- OFILaser Blood Flow Kit2Product Code
- PFYLow Patient Acuity Monitoring System2Product Code
- PLBMultivariate Vital Signs Index2Product Code
- PPWAdjunctive Cardiovascular Status Indicator2Product Code
- QAQAdjunctive Predictive Cardiovascular Indicator2Product Code
- QDAElectrocardiograph Software For Over-The-Counter Use2Product Code
- QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use2Product Code
- QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator2Product Code
- QNVAdjunctive Hemodynamic Indicator With Decision Point2Product Code
- QOKHardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate2Product Code
- QUOAdjunctive Heart Failure Status Indicator2Product Code
- QXZAdjunctive Epicardial Vascular Physiologic Status Indicator2Product Code
- SARAdjunctive Hemodynamic Indicator With Decision Point For Military Use2Product Code
- SDJAdjunctive Cardiac Amyloidosis Status Indicator2Product Code
- SDYLoss Of Pulse Notification Software2Product Code
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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TRACET AG 4000
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K904512
- 510(k) Type
- Traditional
- Applicant
- LECTEC CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/31/1991
- Days to Decision
- 121 days