510(k) K061256
K061256 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "SMARTMONITOR 2PS". The FDA issued a decision of Substantially Equivalent on August 2, 2006. The device falls under product code NPF (Monitor, Apnea, Home Use), a Class II device regulated under 21 CFR 868.2377. Respironics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2006
- Date Received
- May 4, 2006
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Apnea, Home Use
- Device Class
- Class II
- Regulation Number
- 868.2377
- Review Panel
- AN
- Submission Type
Same as the identification for product code FLS, just add home use