Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- ERYDrape, Surgical, Ent2Product Code
- EYXDrape, Pure Latex Sheet, With Self-Retaining Finger Cot2Product Code
- EYYDrape, Urological, Disposable2Product Code
- FXOSuit, Surgical1Product Code
- FXPCover, Shoe, Operating-Room1Product Code
- FXXMask, Surgical2Product Code
- FXYHood, Surgical2Product Code
- FXZHelmet, Surgical1Product Code
- FYAGown, Surgical2Product Code
- FYBGown, Patient2Product Code
- FYCGown, Isolation, Surgical2Product Code
- HMTDrape, Patient, Ophthalmic2Product Code
- HMWDrape, Microscope, Ophthalmic2Product Code
- KGOSurgeon'S Gloves1Product Code
- KGQCream, Gloving, Surgeon'S1Product Code
- KGTDrape, Adhesive, Aerosol1Product Code
- KKXDrape, Surgical2Product Code
- LGXTable, Examination, Medical, Powered1Product Code
- LYUAccessory, Surgical Apparel1Product Code
- MACDecontamination Kit1Product Code
- MMPCover, Barrier, Protective2Product Code
- MSHRespirator, Surgical2Product Code
- K233022Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small2Cleared 510(K)
- K172963Master-Frank N95 Particulate Respirator2Cleared 510(K)
- K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S2Cleared 510(K)
- K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-122Cleared 510(K)
- K141876Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator2Cleared 510(K)
- K1210693M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK2Cleared 510(K)
- K102923BARRIER N95 PARTICULATE RESPIRATOR2Cleared 510(K)
- K102092PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES2Cleared 510(K)
- K102173MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 17122Cleared 510(K)
- K100139SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B1502Cleared 510(K)
- K092824N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 6952Cleared 510(K)
- K090131DS N95 SURGICAL MASKS AND FLAT SURGICAL2Cleared 510(K)
- K080827HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY98102Cleared 510(K)
- K072067N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP00282Cleared 510(K)
- K072359AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C2Cleared 510(K)
- K070692DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK2Cleared 510(K)
- K070168N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C2Cleared 510(K)
- K070782WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F2Cleared 510(K)
- K070139WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB0952Cleared 510(K)
- K0630233M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 18702Cleared 510(K)
- K063747INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A2Cleared 510(K)
- K063334SHANGHAI GANGHAI MODEL GIKO 14002Cleared 510(K)
- K063013PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S2Cleared 510(K)
- K061375RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 17302Cleared 510(K)
- K062665INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS2Cleared 510(K)
- K062663MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS2Cleared 510(K)
- K061859INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS2Cleared 510(K)
- K051182INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS2Cleared 510(K)
- K050193GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR2Cleared 510(K)
- K041855PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S2Cleared 510(K)
- K042267INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP2Cleared 510(K)
- K020474MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N952Cleared 510(K)
- K974068PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL2Cleared 510(K)
- K970448PCM 2000; ISOLAIR APR MODEL 27352Cleared 510(K)
- K960778ISOLAIR APR TYPE N952Cleared 510(K)
- NZPSealant, Microbial2Product Code
- OEANon-Surgical Isolation Gown1Product Code
- OKFBody Fluid Disposal Kit2Product Code
- OKGBody Fluid Clean Up Kit2Product Code
- OKHBody Fluids Barrier Kit2Product Code
- OKIEmergency Response Safety Kit2Product Code
- ONTN95 Respirator With Antimicrobial/Antiviral Agent2Product Code
- OPAPowder-Free Non-Natural Rubber Latex Surgeon'S Gloves1Product Code
- OUKSurgical Mask With Antimicrobial/Antiviral Agent2Product Code
- OVRKit, First Aid, Talking1Product Code
- OXZPediatric/Child Facemask2Product Code
- PIRMercy Tape 2d And 3d Models1Product Code
- PLYAntimicrobial Drapes2Product Code
- PQMSurgical Smoke Precipitator2Product Code
- QBWSurgical Apparel With Material Claims2Product Code
- QMXLabel Or Tag, Non-Sterile1Product Code
- QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection2Product Code
- QSOMedical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- 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
PCM 2000; ISOLAIR APR MODEL 2735
- Page Type
- Cleared 510(K)
- 510(k) Number
- K970448
- 510(k) Type
- Traditional
- Applicant
- TECNOL MEDICAL PRODUCTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/30/1997
- Days to Decision
- 83 days
- Submission Type
- Summary