510(k) K960309
K960309 is an FDA 510(k) premarket notification submitted by Airsep Corp. for the device "AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on February 28, 1997. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Airsep Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1997
- Date Received
- January 5, 1996
- 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