The following data is part of a premarket notification filed by Advanced Sterilization Products (asp) with the FDA for Evotech Ecr.
| Device ID | K152189 |
| 510k Number | K152189 |
| Device Name: | EVOTECH ECR |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | Advanced Sterilization Products (ASP) 33 Technology Dr Irvine, CA 92618 |
| Contact | Nazanin Yacobi |
| Correspondent | Nazanin R Yacobi Advanced Sterilization Products (ASP) 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 | 2015-08-05 |
| Decision Date | 2016-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333241637 | K152189 | 000 |
| 04961333241491 | K152189 | 000 |
| 04961333241507 | K152189 | 000 |
| 04961333241514 | K152189 | 000 |
| 04961333241521 | K152189 | 000 |
| 04961333241538 | K152189 | 000 |
| 04961333241545 | K152189 | 000 |
| 04961333241552 | K152189 | 000 |
| 04961333241569 | K152189 | 000 |
| 04961333241576 | K152189 | 000 |
| 04961333241583 | K152189 | 000 |
| 04961333241590 | K152189 | 000 |
| 04961333241606 | K152189 | 000 |
| 04961333241613 | K152189 | 000 |
| 04961333241620 | K152189 | 000 |
| 04961333241484 | K152189 | 000 |