700-F SERIES STIMULATION ELECTRODES
FDA 510(k) clearance K964469 · decided 1996-12-11
Clearance details
- K-number
- K964469
- Device name
- 700-F SERIES STIMULATION ELECTRODES
- Applicant
- Cardiotronics Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-07
- Decision date
- 1996-12-11
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- LDD
- Device class
- 2
- Regulation number
- 870.5300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cardiotronics Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect recall (Z-0461-2015) | ConMed Corporation | 2014-12-04 |
| CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to recall (Z-0462-2015) | ConMed Corporation | 2014-12-04 |
| R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715, NON-STERI recall (Z-0856-2012) | ConMed Corporation | 2012-01-25 |
| R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE recall (Z-0735-2012) | ConMed Corporation | 2012-01-12 |