Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- OGPCricothyrotomy Kit2Product Code
- OGVTracheostomy Cleaning Tray2Product Code
- OGWTracheostomy Kit2Product Code
- MYBPillow, Cervical (For Mild Sleep Apnea)2Product Code
- EPNPump, Nebulizer, Manual1Product Code
- EPPSplint, Nasal1Product Code
- ETFUnit, Examining/Treatment, Ent1Product Code
- K953457JEDMED SPECTRUM ENT CABINET1Cleared 510(K)
- K945395PREMIER MIRROR WARMER1Cleared 510(K)
- K932470LANGGASSE 901Cleared 510(K)
- K911901MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE1Cleared 510(K)
- K910781#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES1Cleared 510(K)
- K910243MOBILE TREATMENT CART1Cleared 510(K)
- K896273SYSTEMA ENT CABINET1Cleared 510(K)
- K896298JEDMED S CHAIR1Cleared 510(K)
- K881958JEDMED MAXIM ENT CABINET1Cleared 510(K)
- K860940MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT1Cleared 510(K)
- K855021LARYNGEAL MIRROR PRE-WARMER1Cleared 510(K)
- K843046RELIANCE TREATMENT CABINET1Cleared 510(K)
- K833882INSTRUMENT CABINET1Cleared 510(K)
- K823226SN-100 DOCTOR'S ROUND1Cleared 510(K)
- K822252ENT TREATMENT UNITS1Cleared 510(K)
- K822531MULTIPLE, ENT CABINET #4481Cleared 510(K)
- K822530MULTIPLE, ENT CHAIR #4181Cleared 510(K)
- K822016NAGASHIMA SN-SP UNIT AND CHAIR1Cleared 510(K)
- K813490VERSION OF A CLOSED-FLOW SYS. CALORIC1Cleared 510(K)
- K810148ATMOSET1Cleared 510(K)
- K802712ENTERMED ENTUNIT1Cleared 510(K)
- K801742NEW FINE MODEL ENT TREATMENT UNIT1Cleared 510(K)
- K801738NOBLE MEDEL ENT TREATMENT UNIT1Cleared 510(K)
- K801739NOBLE MODEL DOUBLESIDED TREATMENT UNIT1Cleared 510(K)
- K801740TREATMENT UNIT FOR DOCTOR'S ROUNDS1Cleared 510(K)
- K801741PRETTY MODEL ENT TREATMENT UNIT1Cleared 510(K)
- K800756DUNRICH TABLES1Cleared 510(K)
- K800526SMR H-CHAIR1Cleared 510(K)
- K791936ATMOS ENT CABINET PRACTICA 21Cleared 510(K)
- K791935ATMOS ENT CABINET PRACTICA 31Cleared 510(K)
- K791934ATMOS ENT TREATMENT SYSTEM SERVANT 31Cleared 510(K)
- K782064TABLE, EXAMINING-TWO EIGHTY1Cleared 510(K)
- EWTDevice, Antichoke, Suction3Product Code
- EWWDevice, Antichoke, Tongs3Product Code
- JPWPump, Nebulizer, Electrically Powered1Product Code
- KCJApplicator, Ent1Product Code
- KCLBlower, Powder, Ent1Product Code
- KCMDropper, Ent1Product Code
- KCNEar Wick1Product Code
- KCONasal Spray, Ent Delivery1Product Code
- KCPSyringe, Ent1Product Code
- KMAIrrigator, Powered Nasal1Product Code
- KTHDevice, Anti-Stammering1Product Code
- LRDApplicator, Ent Drug1Product Code
- PKAExternal Upper Esophageal Sphincter (Ues) Compression Device2Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- 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
VERSION OF A CLOSED-FLOW SYS. CALORIC
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K813490
- 510(k) Type
- Traditional
- Applicant
- THOMAS M. FOTI, M.D.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/7/1982
- Days to Decision
- 34 days