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
- DRMCompressor, Cardiac, External2Product Code
- K221700AutoPulse NXT Resuscitation System2Cleared 510(K)
- K211289RMU-2000 Automated Chest Compression System2Cleared 510(K)
- K173553LUCAS 3 Chest Compression System2Cleared 510(K)
- K161768LUCAS 3 Chest Compression System2Cleared 510(K)
- K153628ROSC-U Mini Chest Compressor (RMCC)2Cleared 510(K)
- K141809RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM2Cleared 510(K)
- K112998AUTOPULSE RESUSCITATION SYSTEM MODEL 10002Cleared 510(K)
- K102068MINIATURIZE CHEST COMPRESSOR (MCC)2Cleared 510(K)
- K090422LUCAS 22Cleared 510(K)
- K072527AUTOPULSE RESUSCITATION SYSTEM, MODEL 1002Cleared 510(K)
- K073079THUMPER, MODEL: 10082Cleared 510(K)
- K063602AUTOPULSE RESUSCITATION SYSTEM MODEL1002Cleared 510(K)
- K062401MODIFICATION TO LUCAS2Cleared 510(K)
- K062119HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 1002Cleared 510(K)
- K053403LUCAS2Cleared 510(K)
- K024215ENERTRON CPR JACK2Cleared 510(K)
- K040453AUTOPULSE RESUSCITATION SYSTEM, MODEL 1002Cleared 510(K)
- K032852MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 1002Cleared 510(K)
- K022345AUTOPULSE RESUSCITATION SYSTEM2Cleared 510(K)
- K011046AUTOPULSE, MODEL 1002Cleared 510(K)
- K972525THUMPER2Cleared 510(K)
- K962237THUMPER CARDIOPULMONARY RESUSCITATOR2Cleared 510(K)
- K951124CAD-2000 CARDIAC ASSIST DEVICE2Cleared 510(K)
- K922093HASKEL CPR2Cleared 510(K)
- K871271HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR.2Cleared 510(K)
- K871272HUNTLEIGH FLOWPAC FP20002Cleared 510(K)
- K855004SWELL-RELIEF2Cleared 510(K)
- K854734MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE2Cleared 510(K)
- K851139THUMPER CARDIOPULMONARY RESUSCITATOR 10052Cleared 510(K)
- K841275FINE NEEDLE ASPIRATION DEVICE2Cleared 510(K)
- K841822KEYMED SIGMOIDOSCOPE SUCTION UNIT2Cleared 510(K)
- K841410BUSH NECK W/TAP2Cleared 510(K)
- K833879CARDIOPULMONARY RESUSCITATOR2Cleared 510(K)
- K811987OXY-QUIK MARK IV OXYGEN INHALATOR2Cleared 510(K)
- K811909CARDIOPULMUNARY RESUSCITATOR2Cleared 510(K)
- K801945SAVE MOR2Cleared 510(K)
- K801947CPR TRAVELER2Cleared 510(K)
- K801946CPR HELPER2Cleared 510(K)
- K792451PNEUPAC RESUSCITATOR INSTANT ACTION SET2Cleared 510(K)
- K792458PNEUPAC TEST SET, PT.#500-A2502Cleared 510(K)
- K792454PNEUPAC RESUSCITATOR INSTANT ACTION SET2Cleared 510(K)
- K792452PNEUPAC RESUSCITATOR INSTANT ACTION SET2Cleared 510(K)
- K791145CPR CONTROL SYSTEM2Cleared 510(K)
- K790513HLA-20002Cleared 510(K)
- K761194HLR QUICK-FIT HEART-LUNG RESUSCITATOR2Cleared 510(K)
- 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
SWELL-RELIEF
- Page Type
- Cleared 510(K)
- 510(k) Number
- K855004
- 510(k) Type
- Traditional
- Applicant
- D.A. SCHULMAN, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/12/1986
- Days to Decision
- 61 days