The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Aquacade.
| Device ID | K811524 |
| 510k Number | K811524 |
| Device Name: | AQUACADE |
| Classification | Warmer, Irrigation Solution |
| Applicant | RESPIRATORY CARE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LHC |
| CFR Regulation Number | 890.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-29 |
| Decision Date | 1981-07-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AQUACADE 73018786 1007331 Dead/Expired |
RESPIRATORY CARE, INC. 1974-04-15 |
![]() AQUACADE 73004083 1022641 Dead/Expired |
RAMCO MANUFACTURING, INC. 1973-10-19 |
![]() AQUACADE 72387348 0937744 Dead/Expired |
AVON PRODUCTS, INC. 1971-03-25 |