ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1; OOM103/-1/-1M; OOM104; OOM105; 00M106— 510(k) K082655
Substantially EquivalentEnvitec-Wismar GmbH
FDA 510(k) clearance K082655 for ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1; OOM103/-1/-1M; OOM104; OOM105; 00M106, Substantially Equivalent on 2008-11-25. Applicant: Envitec-Wismar GmbH. Device class: 2.
Clearance details
- Device name as filed
- ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106
- Applicant
- Envitec-Wismar GmbH
- Product code
- Code CCL
- Device class
- Class 2
- Regulation
- 21 CFR 868.1720
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Egale, WI, US
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Adverse events under product code CCL
product code CCL- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.