The following data is part of a premarket notification filed by Children's Mercy Hospital with the FDA for Mercy Babytape.
| Device ID | K191174 |
| 510k Number | K191174 |
| Device Name: | Mercy BabyTAPE |
| Classification | Mercy Tape 2d And 3d Models |
| Applicant | Children's Mercy Hospital 2401 Gilham Road Kansas City, MO 64108 |
| Contact | Susan Abdel-rahman |
| Correspondent | Susan Abdel-rahman, Pharmd. The Emmes Company, LLC Children's Mercy Hospital 2401 Gilham Road Kansas City, MO 64108 -4619 |
| Product Code | PIR |
| Subsequent Product Code | FRW |
| Subsequent Product Code | FTY |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-01 |
| Decision Date | 2019-10-10 |
| Summary: | summary |