The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Evotech Ecr.
| Device ID | K140977 |
| 510k Number | K140977 |
| Device Name: | EVOTECH ECR |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Reuben Lawson |
| Correspondent | Reuben Lawson ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-16 |
| Decision Date | 2014-12-22 |
| Summary: | summary |