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
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- DRKDc-Defibrillator, High Energy, (Including Paddles)3Product Code
- DRLTester, Defibrillator2Product Code
- K190437Delta 33002Cleared 510(K)
- K182905UniPulse2Cleared 510(K)
- K153210Defibrillator Analyzer Variable Load2Cleared 510(K)
- K110192DEFIBRILLATOR ANALYZER - DA-2006P2Cleared 510(K)
- K083347IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS2Cleared 510(K)
- K072114IMPULSE 6000D/7000DP2Cleared 510(K)
- K062099PHASE 3, MODEL DT-12Cleared 510(K)
- K030547MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE2Cleared 510(K)
- K963190QA-40M DEFIBRILLATOR TESTER2Cleared 510(K)
- K961595DEFIBRILLATOR ANALYZER, DELTA 10002Cleared 510(K)
- K954391MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER2Cleared 510(K)
- K941404IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER2Cleared 510(K)
- K934254IMPULSE 3000 DEFIBRILLATOR ANALYZER2Cleared 510(K)
- K904159DEFIBRILLATOR ANALYZER MODEL QED-52Cleared 510(K)
- K896985ZAP-GUARD2Cleared 510(K)
- K895525MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER2Cleared 510(K)
- K880780HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG2Cleared 510(K)
- K790394DEFIBRILLATOR INTERAL PADDLE TEST LOAD2Cleared 510(K)
- K782033CARDIAC CARE Q/C TEST KIT2Cleared 510(K)
- DRMCompressor, Cardiac, External2Product Code
- DRNDevice, Counter-Pulsating, External2Product Code
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)2Product Code
- DRPTourniquet, Automatic Rotating2Product Code
- DWJSystem, Thermal Regulating2Product Code
- DXECatheter, Embolectomy2Product Code
- DXFCatheter, Septostomy2Product Code
- JOWSleeve, Limb, Compressible2Product Code
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)2Product Code
- LHXTrousers, Anti-Shock2Product Code
- LIXAid, Cardiopulmonary Resuscitation2Product Code
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous2Product Code
- MKJAutomated External Defibrillators (Non-Wearable)3Product Code
- MMXDevice, Percutaneous Retrieval2Product Code
- MPCAtrial Defibrillator3Product Code
- MPDAuxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator2Product Code
- MPEAuxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker2Product Code
- NSAOver-The-Counter Automated External Defibrillator3Product Code
- NZEHyperthermia Monitor2Product Code
- PJBCatheter Remote Control System2Product Code
- PLAEsophageal Thermal Regulation And Gastric Suctioning Device2Product Code
- PMJCpr Aid Feedback Device (No Software)2Product Code
- PMKCpr Aid Device Without Feedback1Product Code
- PPSSleeve, Head And Neck, Compressible2Product Code
- QEWPeripheral Mechanical Thrombectomy With Aspiration2Product Code
- QEXCoronary Mechanical Thrombectomy With Aspiration2Product Code
- QEYMechanical Thrombolysis Catheter2Product Code
- QEZAspiration Thrombectomy Catheter2Product Code
- QLZSeptostomy Catheter, Reprocessed2Product Code
- QMSAdjunctive Open Loop Fluid Therapy Recommender2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ChemistryReview Panel
- DentalReview Panel
- 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
MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K954391
- 510(k) Type
- Traditional
- Applicant
- BIO-TEK INSTRUMENTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/17/1995
- Days to Decision
- 59 days
- Submission Type
- Summary