STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002— 510(k) K081264
Substantially EquivalentChildren'S Health First, Inc.
FDA 510(k) clearance K081264 for STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002, Substantially Equivalent on 2009-02-13. Applicant: Children'S Health First, Inc..
Clearance details
- Applicant
- Children'S Health First, Inc.
- Product code
- Code FMQ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Adverse events under product code FMQ
product code FMQ- Death
- 8
- Total
- 8
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.