FDA device listing
NeuRx Diaphragm Pacing System,NeuRx DPS
FDA device listing 1548301151 · Synapse Biomedical Inc.
Key facts
| Proprietary names | NeuRx Diaphragm Pacing System,NeuRx DPS |
|---|---|
| Owner/operator | Synapse Biomedical Inc. |
| Owner/operator number | 10024968 |
| Premarket submissions | H100006 |
| Product codes | OIR |
| Device names | OIR - Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.OIR |
| Review panels | Anesthesiology |
| Registered establishments | SYNAPSE BIOMEDICAL INC. |
| Establishment registrations | 3005868392 |
| FEI numbers | 3005868392 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database