FDA device listing
11-51DA SmartHeart Deluxe Pulse Oximeter,11-51D SmartHeart Deluxe Pulse Oximeter,73-51D Leader Pulse Oximeter
FDA device listing 1578877356 · JOYTECH HEALTHCARE CO. LTD.
Key facts
| Proprietary names | 11-51DA SmartHeart Deluxe Pulse Oximeter,11-51D SmartHeart Deluxe Pulse Oximeter,73-51D Leader Pulse Oximeter |
|---|---|
| Owner/operator | JOYTECH HEALTHCARE CO. LTD. |
| Owner/operator number | 10054061 |
| Product codes | PGJ |
| Device names | PGJ - Oximeter, Wellness |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2700 |
| Review panels | Cardiovascular |
| Registered establishments | JOYTECH HEALTHCARE CO., LTD., JOYTECH HEALTHCARE CO.,LTD., RENS MEDCARE (CAMBODIA) CO.,LTD. |
| Establishment registrations | 3013053058, 3024790242, 3030671608 |
| FEI numbers | 3013053058, 3024790242, 3030671608 |
| Establishment operations | Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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