The following data is part of a premarket notification filed by Rapid Aid Corp. with the FDA for Infant Transport Mattress Warmer With Disc.
| Device ID | K163295 |
| 510k Number | K163295 |
| Device Name: | Infant Transport Mattress Warmer With Disc |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | RAPID AID CORP. 4120 A SLADEVIEW CRESENT Mississauga, CA L5l 5z3 |
| Contact | Laureta Prifti |
| Correspondent | Diane Horwitz Mandell Horwitz Consultants 2995 Steven Martin Dr. Fairfax, VA 22031 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-22 |
| Decision Date | 2017-07-24 |
| Summary: | summary |