The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad Nx Sterilizer.
| Device ID | K162007 |
| 510k Number | K162007 |
| Device Name: | STERRAD NX Sterilizer |
| Classification | Sterilizer, Chemical |
| Applicant | Advanced Sterilization Products 33 Technology Dr. Irvine, CA 92618 |
| Contact | Nazanin Yacobi |
| Correspondent | Nazanin Yacobi Advanced Sterilization Products 33 Technology Dr. Irvine, CA 92618 |
| Product Code | MLR |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-20 |
| Decision Date | 2017-02-16 |
| Summary: | summary |