510(k) K970971
K970971 is an FDA 510(k) premarket notification submitted by Uromed Corp. for the device "URO MED NERVE STIMULATOR". The FDA issued a decision of Substantially Equivalent on October 27, 1997. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Uromed Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 1997
- Date Received
- March 17, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- EN
- Submission Type