FDA device listing
989803149981 and 989803149991 SMART Pads III,989803150031 Pediatric Key,989803150161 Primary Battery,989803158211 and…
FDA device listing 1444070357 · Philips Medical Systems International BV
Key facts
| Proprietary names | 989803149981 and 989803149991 SMART Pads III,989803150031 Pediatric Key,989803150161 Primary Battery,989803158211 and 989803158221 DP Pads |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | P160028 |
| Product codes | MKJ |
| Device names | MKJ - Automated External Defibrillators (Non-Wearable) |
| Device class | Class III |
| Classification regulations (21 CFR) | 870.5310 |
| Review panels | Cardiovascular |
| Registered establishments | Philips Electronics Ltd, Philips North America LLC |
| Establishment registrations | 3030677, 3000126629, 3012607778 |
| FEI numbers | 1000524572, 3000126629, 3012607778 |
| Establishment operations | Foreign Exporter, 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