ENVITEC MYSIGN O OXYGEN MEASURING DEVICE— 510(k) K122290
Substantially EquivalentEnvitec-Wismar GmbH
FDA 510(k) clearance K122290 for ENVITEC MYSIGN O OXYGEN MEASURING DEVICE, Substantially Equivalent on 2013-01-23. Applicant: Envitec-Wismar GmbH. Device class: 2.
Clearance details
- 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
Recent devices under product code CCL
view allMore clearances from Envitec-Wismar GmbH
view all- K133064 — MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31
- K102270 — ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN
- K090438 — REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR
- K082655 — ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1; OOM103/-1/-1M; OOM104; OOM105; 00M106
- K070193 — ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES
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.