FDA device listing
50-0018, 50-0034, 50-0035, 50-0044, 50-0045, 50-0169,EVO Recorder,Holter Kits,LC12, LC12CH, LC12GER, LC12KIT, LC12KITUS…
FDA device listing 1982007721 · SPACELABS HEALTHCARE, INC.
Key facts
| Proprietary names | 50-0018, 50-0034, 50-0035, 50-0044, 50-0045, 50-0169,EVO Recorder,Holter Kits,LC12, LC12CH, LC12GER, LC12KIT, LC12KITUS, LC12US,LCF3LCH, LCF3LGER, LCF3LUK, LCFKIT, LCF4L,Lifecard CF (LCF),patient cables and leadwires |
|---|---|
| Owner/operator | SPACELABS HEALTHCARE, INC. |
| Owner/operator number | 2022906 |
| Premarket submissions | K011837 |
| Product codes | MWJ |
| Device names | MWJ - Electrocardiograph, Ambulatory (Without Analysis) |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2800 |
| Review panels | Cardiovascular |
| Registered establishments | Spacelabs Healthcare Inc., SPACELABS HEALTHCARE LTD. |
| Establishment registrations | 9611295, 3010157426 |
| FEI numbers | 3002807992, 3010157426 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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