The following data is part of a premarket notification filed by Aqua-tools with the FDA for Filtray 2g Disposable Water Filters.
| Device ID | K191563 |
| 510k Number | K191563 |
| Device Name: | FILTRAY 2G Disposable Water Filters |
| Classification | System, Water Purification, General Medical Use |
| Applicant | aqua-tools 26, Rue Charles Edouard Jeanneret Poissy, FR 78300 |
| Contact | Virginie S. Grondin |
| Correspondent | Virginie S. Grondin aqua-tools 26, Rue Charles Edouard Jeanneret Poissy, FR 78300 |
| Product Code | NHV |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-13 |
| Decision Date | 2019-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760279731070 | K191563 | 000 |
| 03760279730400 | K191563 | 000 |
| 03760279730431 | K191563 | 000 |
| 03760279730547 | K191563 | 000 |
| 03760279730370 | K191563 | 000 |
| 03760279730455 | K191563 | 000 |
| 03760279730981 | K191563 | 000 |
| 03760279730998 | K191563 | 000 |
| 03760279731001 | K191563 | 000 |
| 03760279731018 | K191563 | 000 |
| 03760279731025 | K191563 | 000 |
| 03760279731032 | K191563 | 000 |
| 03760279731049 | K191563 | 000 |
| 03760279731056 | K191563 | 000 |
| 03760279731063 | K191563 | 000 |
| 03760279730004 | K191563 | 000 |