Analyzer, Pacemaker Generator Function
PSA Cable
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | DTC |
| Device type | Analyzer, Pacemaker Generator Function |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3630 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-11-16 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Ethylene Oxide |
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6763 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| External Pacemaker Analyzer | Netech Corp. | 2 |
| CareLink SmartSync™ Common Application | Medtronic, Inc. | 2 |
| PK-141/2.8m | Biotronik SE & Co. KG | 1 |
| CareLink SmartSync™ Azure Astra Application | Medtronic, Inc. | 1 |
| CareLink SmartSync™ | Medtronic, Inc. | 1 |
| External Pacemaker Ananlyzer | Netech Corp. | 1 |
| SigmaPace 1000 | Fluke Electronics Corporation | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170815 | 2017-07-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.