510(k) K080036
K080036 is an FDA 510(k) premarket notification submitted by Dyansys, Inc. for the device "PORTABLE ECSCOPE 12I". The FDA issued a decision of Substantially Equivalent on January 16, 2008. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Dyansys, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2008
- Date Received
- January 7, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type