510(k) K110693
K110693 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "PACEART OPTIMA SYSTEM SOFTWARE". The FDA issued a decision of Substantially Equivalent on June 8, 2011. The device falls under product code KRE (Analyzer, Pacemaker Generator Function, Indirect), a Class II device regulated under 21 CFR 870.3640. Medtronic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 2011
- Date Received
- March 11, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Pacemaker Generator Function, Indirect
- Device Class
- Class II
- Regulation Number
- 870.3640
- Review Panel
- CV
- Submission Type