Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Elekon Industries U.S.A., Inc. with 6 510(k) clearances. The most recent is a 510(k) clearance dated Dec 29, 2004: DISPOSABLE NON-ADHESIVE SPO2 SENSORS.
| Dec 29, 2004 | DISPOSABLE NON-ADHESIVE SPO2 SENSORSK042705 · DQA | 510(k) clearances |
| Dec 6, 2004 | FLEXI-STAT SP02 EAR SENSORK042675 · DPZ | 510(k) clearances |
| Nov 26, 2004 | REUSABLE FINGER CLIP SPO2 SENSORSK042704 · DQA | 510(k) clearances |
| Sep 14, 2004 | FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORSK041522 · DQA | 510(k) clearances |
| Sep 2, 2004 | FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)K041647 · DQA | 510(k) clearances |
| Jul 29, 2004 | FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)K041644 · DQA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
