Anesthesiology
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- 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
- 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
- CAHFilter, Bacterial, Breathing-Circuit2Product Code
- MAJCatheter, Percutaneous, Intraspinal, Short Term2Product Code
- OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)1Product Code
- LEYSet, Oral Administration2Product Code
- NIHDisinfectant, Subsystem, Water Purification2Product Code
- NIIDisinfectant, Dialysate Delivery System2Product Code
- FLJUnit, Airflow, Laminar2Product Code
- FRTUnit, Isolation, Surgical2Product Code
- FYDApparatus, Exhaust, Surgical2Product Code
- K240127PlumeSafe X5 Smoke Management System2Cleared 510(K)
- K2337898Q10 Surclear Smoke Plume Evacuation System2Cleared 510(K)
- K213068Medline Smoke Evacuation Shroud2Cleared 510(K)
- K202944NEBULAE SRS Laparoscopic Surgical Smoke Removal System2Cleared 510(K)
- K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor2Cleared 510(K)
- K192035EvaQMax Smoke Evacuation System2Cleared 510(K)
- K191328Megadyne Foot Switch2Cleared 510(K)
- K182224SafeAir Smoke Evacuator compact2Cleared 510(K)
- K173108Smoklean2Cleared 510(K)
- K163659Crystal Vision2Cleared 510(K)
Show All 75 Submissions
- ORCAir Filter Portable Apparatus2Product Code
- QGIAir-Handling Apparatus Accessory1Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
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- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
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- General and Plastic SurgeryReview Panel
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- UnknownReview Panel
EvaQMax Smoke Evacuation System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K192035
- 510(k) Type
- Traditional
- Applicant
- Bio Protech, Inc.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/29/2019
- Days to Decision
- 30 days
- Submission Type
- Statement