510(k) K041568
K041568 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "EOCD". The FDA issued a decision of Substantially Equivalent on July 21, 2004. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Respironics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2004
- Date Received
- June 10, 2004
- Clearance Type
- Abbreviated
- 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