510(k) K002834
K002834 is an FDA 510(k) premarket notification submitted by Srs Medical Systems, Inc. for the device "SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR". The FDA issued a decision of Substantially Equivalent on November 29, 2000. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Srs Medical Systems, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 2000
- Date Received
- September 12, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Perineometer
- Device Class
- Class II
- Regulation Number
- 884.1425
- Review Panel
- GU
- Submission Type