CareLink SmartSync Device Manager - Pacing System Analyzer— 510(k) K163008
Substantially EquivalentMedtronic, Inc.
FDA 510(k) clearance K163008 for CareLink SmartSync Device Manager - Pacing System Analyzer, Substantially Equivalent on 2017-02-28. Applicant: Medtronic, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic, Inc.
- Product code
- Code DTA
- Device class
- Class 2
- Regulation
- 21 CFR 870.3720
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mounds View, MN, US
Recent devices under product code DTA
view all- K101982 — MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180
- K073230 — MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
- K050884 — ADAPTER CABLE
- K033613 — MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
- K022360 — ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.
More clearances from Medtronic, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.