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
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- DSTClip, Vena-Cava2Product Code
- DSWBag, Polymeric Mesh, Pacemaker1Product Code
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter2Product Code
- DSZPacemaker Battery3Product Code
- DTATester, Pacemaker Electrode Function2Product Code
- DTBPermanent Pacemaker Electrode3Product Code
- DTCAnalyzer, Pacemaker Generator Function2Product Code
- DTDPacemaker Lead Adaptor2Product Code
- DTEPulse-Generator, Pacemaker, External2Product Code
- K241781Solo Pace Control2Cleared 510(K)
- K232721Lifetech Cardio Temporary Pacemaker2Cleared 510(K)
- K201011Medtronic Model 5392 External Pulse Generator (EPG)2Cleared 510(K)
- K190825Medtronic Model 5392 External Pulse Generator (EPG)2Cleared 510(K)
- K182839Lifetech Cardio Model 8301 Temporary Pacemaker2Cleared 510(K)
- K181973Medtronic Model 5392 External Pulse Generator (EPG)2Cleared 510(K)
- K180873Medtronic Model 53401 External Pulse Generator (EPG)2Cleared 510(K)
- K162054Medtronic Temporary External Pacemaker 534012Cleared 510(K)
- K162550Medtronic Model 5392 External Pulse Generator (EPG)2Cleared 510(K)
- K150246Medtronic Model 5392 External Pulse Generator (EPG)2Cleared 510(K)
- K132924MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)2Cleared 510(K)
- K123916PSA SERIES2Cleared 510(K)
- K042708ERA 3000 PACING SYSTEM ANALYZER2Cleared 510(K)
- K033130PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR2Cleared 510(K)
- K023080GALIX PACESTAR2Cleared 510(K)
- K022939OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES2Cleared 510(K)
- K020896OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE2Cleared 510(K)
- P920032MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER2PMA Approval
- P920032BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 41702PMA Approval
- K011980ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 48252Cleared 510(K)
- P920032MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER2PMA Approval
- K002204PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V2Cleared 510(K)
- K001180TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 5282Cleared 510(K)
- K970347MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM2Cleared 510(K)
- K971474MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL2Cleared 510(K)
- K964190ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER2Cleared 510(K)
- K970497PACE 101H2Cleared 510(K)
- K960676ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-40042Cleared 510(K)
- K940467REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-6012Cleared 510(K)
- K934016POWERCHARGER2Cleared 510(K)
- K925143MODEL 4800 ACCUPACE PACING SYSTEM ANALYER2Cleared 510(K)
- K923621EXTERNAL DEMAND PACEMAKER2Cleared 510(K)
- K923398CPI MODEL 22152Cleared 510(K)
- K915364CHRONOCOR VI MODEL 50122Cleared 510(K)
- K913805MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER2Cleared 510(K)
- K912507CPI MODEL 2215 & SEAMED MODEL 34002Cleared 510(K)
- K910237MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR2Cleared 510(K)
- K902679MODELS 4201, 4231 & 4235 EXTENSION CABLES2Cleared 510(K)
- K900220TRANS-PACE 1002Cleared 510(K)
- K896352MODEL EC4542G MINIATURE2Cleared 510(K)
- K893633MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE2Cleared 510(K)
- K883930SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY2Cleared 510(K)
- K872551SEAMED MODEL 32002Cleared 510(K)
- K871915MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC45432Cleared 510(K)
- K853194ERA-202Cleared 510(K)
- K870323MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER2Cleared 510(K)
- K863903SEA MED MODEL 60002Cleared 510(K)
- K854648SEAMED MODEL 40002Cleared 510(K)
- K850822CHRONOCOR V EXTERNAL PACER, MODEL 297A2Cleared 510(K)
- K843807SEAMED MODEL 60002Cleared 510(K)
- K843777SEAMED 40002Cleared 510(K)
- K831768EXTERNAL PULSE GENERATOR FOR TEMP. STIM2Cleared 510(K)
- K831381RAPID ATRIAL PACER2Cleared 510(K)
- K823048SEA MED MODEL 8802Cleared 510(K)
- K821791EXTERNAL PULSE GENERATOR - EV45422Cleared 510(K)
- K820570SEAMED, #540 - SIEMENS, #146F TELECTRO2Cleared 510(K)
- K811092STERILE PACKAGING2Cleared 510(K)
- K810566SIEMENS MODEL 146-146A EXTERNAL PULSE G2Cleared 510(K)
- K803313PACING SYSTEM ANALYZER2Cleared 510(K)
- K802221CHRONOCOR IV MODEL 2502Cleared 510(K)
- K801055COMPUPACE, 524-01 PACER SYSTEM COMPUTER2Cleared 510(K)
- K801953EXTERNAL, TEMP. PORTABLE CARDIAC GENER2Cleared 510(K)
- K801596CYNERGY MODEL 1842Cleared 510(K)
- K792536CYNERGY MODEL 1822Cleared 510(K)
- K800088PACEMAKER ELECTRODE INSERTER AIDE2Cleared 510(K)
- K792223PACESETTER MODEL 3502Cleared 510(K)
- K782108MEDTRONIC MODEL 5462Cleared 510(K)
- K781327PULSE GENERATOR, MODEL 240, EXTERNAL2Cleared 510(K)
- DTFTools, Pacemaker Service1Product Code
- DTGMagnet, Test, Pacemaker1Product Code
- DTISizer, Heart-Valve, Prosthesis1Product Code
- DTJHolder, Heart-Valve, Prosthesis1Product Code
- DTKFilter, Intravascular, Cardiovascular2Product Code
- DSPSystem, Balloon, Intra-Aortic And Control2Product Code
- DSRStimulator, Carotid Sinus Nerve3Product Code
- DSSClip, Vascular2Product Code
- DXYImplantable Pacemaker Pulse-Generator3Product Code
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2Product Code
- DYEReplacement Heart-Valve3Product Code
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter2Product Code
- KFJMaterials, Repair Or Replacement, Pacemaker3Product Code
- KRDDevice, Vascular, For Promoting Embolization2Product Code
- KREAnalyzer, Pacemaker Generator Function, Indirect2Product Code
- KRFCharger, Pacemaker1Product Code
- KRGProgrammer, Pacemaker3Product Code
- KRHRing, Annuloplasty2Product Code
- LDFElectrode, Pacemaker, Temporary2Product Code
- MABMarker, Cardiopulmonary Bypass (Vein Marker)2Product Code
- MALGraft, Vascular, Synthetic/Biologic Composite2Product Code
- MFXVessel Guard Or Cover, To Facilitate Revision Surgeries2Product Code
- MOPRotator, Prosthetic Heart Valve1Product Code
- MZYGraft, Vascular, Stainless Steel Tunneler2Product Code
- NHWElectrode, Pacing And Cardioversion, Temporary, Epicardial2Product Code
- NKOSystem, Balloon, Intra-Aortic And Control, Reprocessed3Product Code
- OKRVentricular Bypass (Assist) Device3Product Code
- OMHPericardial Patch To Facilitate Revision Surgeries2Product Code
- OMRVessel Guard Or Cover2Product Code
- OTDEndovascular Suturing System2Product Code
- OVJPulse Generator, External Pacemaker, Dual Chamber2Product Code
- PALPulmonic Replacement Heart ValveFProduct Code
- PCKPediatric Ventricular Assist DeviceFProduct Code
- PNJLeadless Pacemaker3Product Code
- PNSShort-Term Intravascular Filter Catheter2Product Code
- PSQIntracardiac Patch Or Pledget, Biologically Derived2Product Code
- PSTAortic Annuloplasty Ring2Product Code
- QABPacing System Analyzer2Product Code
- 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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- OphthalmicReview Panel
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- UnknownReview Panel
ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K964190
- 510(k) Type
- Traditional
- Applicant
- Biotronik, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/10/1997
- Days to Decision
- 262 days
- Submission Type
- Summary