The following data is part of a premarket notification filed by Fresenius Medical Care Rental Therapies Group, Llc with the FDA for Aquaa.
Device ID | K213507 |
510k Number | K213507 |
Device Name: | AquaA |
Classification | Subsystem, Water Purification |
Applicant | Fresenius Medical Care Rental Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
Contact | Denise Oppermann |
Correspondent | Denise Oppermann Fresenius Medical Care Rental Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-11-01 |
Decision Date | 2022-07-27 |