gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler— 510(k) K172712
Substantially EquivalentGri Medical & Electronic Technology Co., Ltd.
FDA 510(k) clearance K172712 for gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler, Substantially Equivalent on 2017-11-06. Applicant: Gri Medical & Electronic Technology Co., Ltd..
Clearance details
- Applicant
- Gri Medical & Electronic Technology Co., Ltd.
- Product code
- Code FMK
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jiaxing, CN
Adverse events under product code FMK
product code FMK- Injury
- 133
- Malfunction
- 1,278
- Other
- 1
- Total
- 1,412
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.