K243861
- 510(k) number
- K243861
- Device name
- butterflyBVM
- Applicant
- Compact Medical, Inc. IN · US
- Product code
- BTM — Ventilator, Emergency, Manual (Resuscitator)
- Decision date
- 2025-04-25
- Date received
- 2024-12-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K243861.pdf
Official FDA record: K243861
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.