The following data is part of a premarket notification filed by Ardo Medical Ag with the FDA for Ardo Suction Pump Master, Model 30.00.xx; Ardo Suction Pump Senator, Model 31.00.xx.
| Device ID | K011601 |
| 510k Number | K011601 |
| Device Name: | ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | ARDO MEDICAL AG GEWERBESTRASSE 19 Unterageri, CH Ch-6314 |
| Contact | Eva Krahenbuhl |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-05-24 |
| Decision Date | 2001-06-08 |
| Summary: | summary |