Clearance Summary
EME MP3000 MONITORING AND DIAGNOSTIC RESTING ECG received FDA 510(k) clearance under submission number K920867, sponsored by Electro Medical Equipment Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1992-04-10.
- Submission: K920867
- Applicant / Sponsor: Electro Medical Equipment Co., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1992-04-10
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.