The following data is part of a premarket notification filed by Advanced Sterilization Products (asp) with the FDA for Aeroflex(tm) Automatic Endoscope Reprocessor With Autosure(tm) Mrc Monitor.
| Device ID | K181472 |
| 510k Number | K181472 |
| Device Name: | AEROFLEX(TM) Automatic Endoscope Reprocessor With AUTOSURE(TM) MRC Monitor |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | Advanced Sterilization Products (ASP) 33 Technology Drive Irvine, CA 92618 |
| Contact | Andrea L. Ruth |
| Correspondent | Laurie E Cartwright Advanced Sterilization Products (ASP) 33 Technology Drive 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 | 2018-06-04 |
| Decision Date | 2019-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705037048882 | K181472 | 000 |
| 10705037067145 | K181472 | 000 |
| 10705037068753 | K181472 | 000 |
| 20705037048769 | K181472 | 000 |
| 10705037064649 | K181472 | 000 |
| 10705037064670 | K181472 | 000 |
| 10705037064687 | K181472 | 000 |
| 10705037064694 | K181472 | 000 |
| 10705037064700 | K181472 | 000 |
| 10705037064717 | K181472 | 000 |
| 10705037065370 | K181472 | 000 |
| 10705037048717 | K181472 | 000 |