510(k) K003367
K003367 is an FDA 510(k) premarket notification submitted by Srs Medical Systems, Inc. for the device "ORION PLATINUM". The FDA issued a decision of Substantially Equivalent on January 4, 2001. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Srs Medical Systems, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 2001
- Date Received
- October 30, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Biofeedback
- Device Class
- Class II
- Regulation Number
- 882.5050
- Review Panel
- NE
- Submission Type