The following data is part of a premarket notification filed by Ardo Medical Ag with the FDA for Ardo Carum And Calypso Powered Breast Pumps.
| Device ID | K141742 |
| 510k Number | K141742 |
| Device Name: | ARDO CARUM AND CALYPSO POWERED BREAST PUMPS |
| Classification | Pump, Breast, Powered |
| Applicant | ARDO MEDICAL AG 1835 MARKET STREET, 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Yarmela Pavlovic |
| Correspondent | Yarmela Pavlovic ARDO MEDICAL AG 1835 MARKET STREET, 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-27 |
| Decision Date | 2014-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814079022005 | K141742 | 000 |
| 00814079022210 | K141742 | 000 |
| 00814079021442 | K141742 | 000 |
| 00814079022050 | K141742 | 000 |
| 00814079020001 | K141742 | 000 |
| 00814079020049 | K141742 | 000 |
| 00814079020063 | K141742 | 000 |
| 00814079020216 | K141742 | 000 |
| 00814079020605 | K141742 | 000 |
| 00814079020667 | K141742 | 000 |
| 00814079020858 | K141742 | 000 |
| 00814079020872 | K141742 | 000 |
| 00814079020933 | K141742 | 000 |
| 00814079020964 | K141742 | 000 |
| 00814079021022 | K141742 | 000 |
| 00814079021053 | K141742 | 000 |
| 00814079021800 | K141742 | 000 |
| 00814079021909 | K141742 | 000 |
| 07640108054494 | K141742 | 000 |