K191174 is an FDA 510(k) clearance for the Mercy babyTAPE. This device is classified as a Mercy Tape 2d And 3d Models (Class I - General Controls, product code PIR).
Submitted by Children'S Mercy Hospital (Kansas City, US). The FDA issued a Cleared decision on October 10, 2019, 162 days after receiving the submission on May 1, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4800. 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)..
| 510(k) Number | K191174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2019 |
| Decision Date | October 10, 2019 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PIR - Mercy Tape 2d And 3d Models |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |
| Definition | 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). |