510(k) K962766
K962766 is an FDA 510(k) premarket notification submitted by Airsep Corp. for the device "AIRSEP IMPULSE". The FDA issued a decision of Substantially Equivalent on October 10, 1996. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Airsep Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 1996
- Date Received
- July 16, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Conserver, Oxygen
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type