This page includes the latest FDA filings for Rochelle Keen. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3013276158 |
| FEI Number | 3013276158 |
| Name | Rochelle Keen |
| Owner & Operator | Perimeter Medical Imaging, Inc. |
| Contact Address | 1 Yonge Suite 201 Toronto CA-ON Ontario M5E 1E6 CA |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1138, Pilgrims pathway Peach bottom Eldora, PA 17563 US |
| Establishment Type | Develop Specifications But Do Not Manufacture At This Facility |
Device Company | Device | Date |
|---|---|---|
Rochelle Keen [Perimeter Medical Imaging, Inc.] | Perimeter OTIS 2.0 Optical Coherence Tomography System | 2019-03-27 |
Rochelle Keen [Perimeter Medical Imaging, Inc.] | Perimeter OTIS 1B Optical Coherence Tomography System | 2017-10-18 |
Rochelle Keen [Perimeter Medical Imaging, Inc.] | Perimeter Otis? 1.0 Optical Coherence Tomography System | 2016-10-19 |