510(k) K100127
K100127 is an FDA 510(k) premarket notification submitted by Mortara Instrument, Inc. for the device "ELI 230 ELECTROCARDIOGRAPH". The FDA issued a decision of Substantially Equivalent on April 16, 2010. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Mortara Instrument, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 2010
- Date Received
- January 19, 2010
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type