PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT— 510(k) K983232
Substantially EquivalentTz Medical, Inc.
FDA 510(k) clearance K983232 for PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT, Substantially Equivalent on 1999-09-15. Applicant: Tz Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Tz Medical, Inc.
- Product code
- Code DRO
- Device class
- Class 2
- Regulation
- 21 CFR 870.5550
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Oswego, OR, US
Recent devices under product code DRO
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- K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
- K974034 — PORTABLE INTENSIVE CARE UNIT
More clearances from Tz Medical, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.