The following data is part of a premarket notification filed by Chiaro Technology Limited with the FDA for Elvie Stride.
| Device ID | K210936 |
| 510k Number | K210936 |
| Device Name: | Elvie Stride |
| Classification | Pump, Breast, Powered |
| Applicant | Chiaro Technology Limited 2nd Floor 63-66 Hatton Garden London, GB Ec1n 8le |
| Contact | Carre King |
| Correspondent | Marc C. Sanchez Contract In-House Counsel And Consultants, LLC d/b/a FDA Atty 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 | 2021-03-29 |
| Decision Date | 2021-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060442520615 | K210936 | 000 |
| 05060442520622 | K210936 | 000 |