The following data is part of a premarket notification filed by Chiaro Technology Limited with the FDA for Elvie Pump.
| Device ID | K181863 |
| 510k Number | K181863 |
| Device Name: | Elvie Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Chiaro Technology Limited 2nd Floor 63-66 Hatton Garden London, GB Ec1n 8le |
| Contact | Jonathan O'toole |
| Correspondent | Marc C. Sanchez Contract In-House Counsel And Consultants, LLC (d/b/a FDA At 53516 Bickett Chapel Hill, NC 27517 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-12 |
| Decision Date | 2018-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060442521797 | K181863 | 000 |