The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Trusignal Spo2 Adult And Pediatric Adhesive Wrap Disposable Sensor.
| Device ID | K132696 |
| 510k Number | K132696 |
| Device Name: | TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR |
| Classification | Oximeter |
| Applicant | GE HEALTHCARE FINLAND OY 86 PILGRIM ROAD Needham, MA 02492 |
| Contact | Joel Kent |
| Correspondent | Joel Kent GE HEALTHCARE FINLAND OY 86 PILGRIM ROAD Needham, MA 02492 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-29 |
| Decision Date | 2013-09-27 |
| Summary: | summary |