12 devices · 9 companies · 1997 to 2026
Product code MNR: Ventilatory Effort Recorder
12 devices under product code MNR, 1997 to 2026, from 9 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (10 of 12 here), the regulation, and MAUDE report counts by product code.
Ventilatory Effort Recorder. 21 CFR 868.2375, Class II. MAUDE held 126 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| RX-1 SleepK253148 · 510(k) | Vivaquant, Inc. Dba Rhythm Express | Anesthesiology | database entry | |
| CASSIEK252628 · 510(k) | Wesper, Inc. | Anesthesiology | database entry | |
| SANSA HSATK252497 · 510(k) | Huxley Medical | Anesthesiology | database entry | |
| SANSA HSATK250882 · 510(k) | Huxley Medical | Anesthesiology | database entry | |
| TipTraQK243268 · 510(k) | PranaQ Pte. Ltd. | Anesthesiology | database entry | |
| SANSA HSATK244027 · 510(k) | Huxley Medical | Anesthesiology | database entry | |
| Huxley SANSA Home Sleep Apnea TestK240285 · 510(k) | Huxley Medical | Anesthesiology | database entry | |
| AuroraK231355 · 510(k) | EnsoData | Anesthesiology | database entry | |
| Belun Sleep System BLS-100K222579 · 510(k) | Belun Technology Company Limited | Anesthesiology | database entry | |
| MATRx plusK163665 · 510(k) | Zephyr Sleep Technologies | Anesthesiology | database entry | |
| SnoreSoundsK150102 · 510(k) | APPIAN MEDICAL, INC. | Anesthesiology | database entry | |
| SLEEP SYSTEM FOR CLINICS & RESEARCHK955841 · 510(k) | COMPUMEDICS PTD LTD. | Anesthesiology | database entry |
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