Machida America Model AC-5000 Automatic Disinfect.
FDA 510(k) K871712 · Machida America, Inc.
Submission
- Device name
- Machida America Model AC-5000 Automatic Disinfect.
- Applicant
- Machida America, Inc.
Orangeburg, NY, US - Received
- May 4, 1987
- Decision date
- January 14, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NVE – Washer, Cleaner, Automated, Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
This automated device is intended to be used to clean endoscopes. Endoscopes that are intended to be cleaned by the automated cleaner system should have been pre-cleaned and tested for leaks and lumen obstructions according to the instrument manufacturer's instructions and current professional practices prior to processing in the system. The system includes a chemical dispensing system that…
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Questions and answers
When was Machida America Model AC-5000 Automatic Disinfect. cleared by the FDA?
Machida America Model AC-5000 Automatic Disinfect. (K871712) received a 510(k) decision of Substantially Equivalent on January 14, 1988, 255 days after the submission was received.
What is the product code of K871712?
The FDA product code is NVE – Washer, Cleaner, Automated, Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.