2 catalogue numbers from 989803128951, listed by Philips Medical Systems Hsg, under Pacemaker, Cardiac, External Transcutaneous (Non-Invasive). 2 manufacturers in China are registered for this product code.
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | Listed by | Philips Medical Systems Hsg |
| FDA product code | DRO |
| Device type | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5550 |
| Record published | 2017-04-03 |
| Record revised | 2024-06-06 (version 6) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | lot or batch number |
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.