510(k) K103791
K103791 is an FDA 510(k) premarket notification submitted by Commwell , Ltd. for the device "PHYSIOGLOVE ES WITH ECG ANALYSIS". The FDA issued a decision of Substantially Equivalent on October 21, 2011. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Commwell , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2011
- Date Received
- December 27, 2010
- Clearance Type
- Traditional
- 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