510(k) K964469 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
700-F SERIES STIMULATION ELECTRODES
| Applicant | Cardiotronics Systems, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Dec 11, 1996 |
| Received | Nov 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964469
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2014 | ConMed Corporation CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion Terminated |
LDD | None listed |
| Dec 4, 2014 | ConMed Corporation CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pa Terminated |
LDD | None listed |
| Jan 25, 2012 | ConMed Corporation R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715, NON-STERILE, MADE IN USA, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13507
This device, when connected to a monito Terminated |
MLN | None listed |
| Jan 12, 2012 | ConMed Corporation R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13505.
This device, when connected to a Terminated |
LDD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.