This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | MODEL 515 NEONATAL MONIOTR |
| Generic Name | Monitor, Carbon-dioxide, Cutaneous |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| Date Received | 1986-06-19 |
| Decision Date | 1986-11-19 |
| PMA | P840037 |
| Supplement | S001 |
| Product Code | LKD |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 Burnes Park Rd. N., Walling ford, Ct 06492-0333 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840037 | Original Filing | |
| S001 | 1986-06-19 | Normal 180 Day Track |