Clearance Summary
AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL received FDA 510(k) clearance under submission number K881196, sponsored by Biometer Intl. A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1989-06-16.
- Submission: K881196
- Applicant / Sponsor: Biometer Intl. A/S
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1989-06-16
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.