Envitec-Wismar GmbH
Egale, WI, US
Envitec-Wismar GmbH appears in FDA device records in Egale, WI. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Envitec-Wismar GmbH between 2000 and 2014. The busiest year on record is 2000, with 1. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133064 | MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31 | DQA | Substantially Equivalent | |
| K122290 | ENVITEC MYSIGN O OXYGEN MEASURING DEVICE | CCL | Substantially Equivalent | |
| K102270 | ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN | DQA | Substantially Equivalent | |
| K090438 | REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR | DQA | Substantially Equivalent | |
| K082655 | ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 | CCL | Substantially Equivalent | |
| K070193 | ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES | DQA | Substantially Equivalent | |
| K060675 | ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS | DQA | Substantially Equivalent | |
| K043463 | ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS | DQA | Substantially Equivalent | |
| K992215 | MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED | DQA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain