510(k) K172702
K172702 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda, Inc. for the device "Tec 820, Tec 850". The FDA issued a decision of Substantially Equivalent on January 4, 2018. The device falls under product code CAD (Vaporizer, Anesthesia, Non-Heated), a Class II device regulated under 21 CFR 868.5880. Datex-Ohmeda, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 2018
- Date Received
- September 7, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vaporizer, Anesthesia, Non-Heated
- Device Class
- Class II
- Regulation Number
- 868.5880
- Review Panel
- AN
- Submission Type