510(k) K093657
K093657 is an FDA 510(k) premarket notification submitted by Acist Medical Systems, Inc. for the device "ADAGIO RETRACTING ECG LEAD WIRES". The FDA issued a decision of Substantially Equivalent on January 15, 2010. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Acist Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 2010
- Date Received
- November 25, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cable, Transducer And Electrode, Patient, (Including Connector)
- Device Class
- Class II
- Regulation Number
- 870.2900
- Review Panel
- CV
- Submission Type