K242935 is an FDA 510(k) clearance for the Respiration Data Management Software (PAP Link PC). This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by BMC Medical Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on January 15, 2025, 112 days after receiving the submission on September 25, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K242935 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2024 |
| Decision Date | January 15, 2025 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZD - Ventilator, Non-continuous (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |