Data / Medical devices / Tester, Electrode, Surface, Electrocardiographic
Tester, Electrode, Surface, Electrocardiographic (KRC): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Tester, Electrode, Surface, Electrocardiographic (product code KRC, Class 2, 21 CFR 870.2370). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on January 28, 2004, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KRC
- Device class
- 2
- Regulation
- 870.2370
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| China | 3 |
| Germany | 2 |
| United States | 1 |
Makers of Tester, Electrode, Surface, Electrocardiographic
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulsion Medical Systems Se | Aschheim, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 28, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.