510(k) K172648
K172648 is an FDA 510(k) premarket notification submitted by Devilbiss Healthcare, LLC for the device "Drive DeVilbiss iGo 2 Portable Oxygen Concentrator". The FDA issued a decision of Substantially Equivalent on March 23, 2018. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Devilbiss Healthcare, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2018
- Date Received
- September 1, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5440
- Review Panel
- AN
- Submission Type