Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled 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 14, 2026, FDA's public records list Envitec-Wismar GmbH with 9 510(k) clearances. The most recent is a 510(k) clearance dated May 2, 2014: MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER ….
| May 2, 2014 | MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31K133064 · DQA | 510(k) clearances |
| Jan 23, 2013 | ENVITEC MYSIGN O OXYGEN MEASURING DEVICEK122290 · CCL | 510(k) clearances |
| Feb 22, 2011 | ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDENK102270 · DQA | 510(k) clearances |
| Jul 24, 2009 | REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSORK090438 · DQA | 510(k) clearances |
| Nov 25, 2008 | ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106K082655 · CCL | 510(k) clearances |
| May 2, 2007 | ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIESK070193 · DQA | 510(k) clearances |
| Jul 17, 2006 | ENVITEC REUSABLE SOFTIP Y SPO2 SENSORSK060675 · DQA | 510(k) clearances |
| Feb 11, 2005 | ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORSK043463 · 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
