510(k) K133064
K133064 is an FDA 510(k) premarket notification submitted by Envitec-Wismar GmbH for the device "MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31". The FDA issued a decision of Substantially Equivalent on May 2, 2014. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Envitec-Wismar GmbH has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2014
- Date Received
- September 27, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type