The following data is part of a premarket notification filed by Palliare Ltd. with the FDA for Eva 15 Insufflator.
| Device ID | K193520 |
| 510k Number | K193520 |
| Device Name: | EVA 15 Insufflator |
| Classification | Insufflator, Laparoscopic |
| Applicant | Palliare Ltd. Galway Business Park, Dangan Galway, IE H91 92dk |
| Contact | John O'dea |
| Correspondent | Paul Dryden Palliare Ltd C/o ProMedic LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-19 |
| Decision Date | 2020-07-23 |