510(k) K895838
K895838 is an FDA 510(k) premarket notification submitted by Wr Medical Electronics Co. for the device "BRACKMANN EMG MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 27, 1990. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Wr Medical Electronics Co. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 1990
- Date Received
- October 2, 1989
- 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