FDA device listing
12 LEAD ECG, PRECORDIAL LEADS (IEC),2 LEAD ECG, PRECORDIAL LEADS (AHA),5ft Trunk cable with AHA limb leads,5ft Trunk…
FDA device listing 1566966906 · Bernd Richter GmbH
Key facts
| Proprietary names | 12 LEAD ECG, PRECORDIAL LEADS (IEC),2 LEAD ECG, PRECORDIAL LEADS (AHA),5ft Trunk cable with AHA limb leads,5ft Trunk cable with IEC limb leads,8ft Trunk cable with AHA limb leads,8ft Trunk cable with IEC limb leads,Cable Therapy, Quik Combo |
|---|---|
| Owner/operator | Bernd Richter GmbH |
| Owner/operator number | 10046701 |
| 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 | Amphenol Technology Macedonia Bernd Richter, BERND RICHTER GMBH |
| Establishment registrations | 3004035727 |
| FEI numbers | 3004035727 |
| Establishment operations | Contract 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