510(k) K191174
K191174 is an FDA 510(k) premarket notification submitted by Children'S Mercy Hospital for the device "Mercy babyTAPE". The FDA issued a decision of Substantially Equivalent on October 10, 2019. The device falls under product code PIR (Mercy Tape 2d And 3d Models), a Class I device regulated under 21 CFR 878.4800. Children'S Mercy Hospital has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2019
- Date Received
- May 1, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mercy Tape 2d And 3d Models
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- HO
- Submission Type
The Mercy TAPE device (2D and 3D models) is intended for use by health care professionals to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the TAPE device for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC).