Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- PUPEndoscope Maintenance System2Product Code
- FEBAccessories, Cleaning, For Endoscope2Product Code
- DEN240018CORIS System2Cleared 510(K)
- K241168System 83 Revolve Endoscope Washer/Disinfector2Cleared 510(K)
- K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System2Cleared 510(K)
- K230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing System2Cleared 510(K)
- K213833SCOPE BUDDY PLUS Endoscope Flushing Aid2Cleared 510(K)
- K201920Endoscope Reprocessor OER-Elite2Cleared 510(K)
- K173590System 83 Plus Washer/Disinfector2Cleared 510(K)
- K190969ENDOSCOPE REPROCESSOR OER-Elite2Cleared 510(K)
- K181472AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor2Cleared 510(K)
- K181865Acu-sInQ Complete Endoscope Cleaning Aid System2Cleared 510(K)
Show All 58 Submissions
- NVEWasher, Cleaner, Automated, Endoscope2Product Code
- NZAAccessories, Germicide, Cleaning, For Endoscopes2Product Code
- OUJHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist2Product Code
- PSWHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid2Product Code
- 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
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Endoscope Reprocessor OER-Elite
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K201920
- 510(k) Type
- Special
- Applicant
- Olympus Medical Systems Corp.
- Country
- Japan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/1/2020
- Days to Decision
- 53 days
- Submission Type
- Summary