510(k) K003499
K003499 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "REMVIEW SLEEP RECORDER, MODEL 320". The FDA issued a decision of Substantially Equivalent on February 9, 2001. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050. Respironics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2001
- Date Received
- November 13, 2000
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Sleep Assessment
- Device Class
- Class II
- Regulation Number
- 882.5050
- Review Panel
- NE
- Submission Type