The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Foley Catheters With Temperature Probe.
| Device ID | K061918 |
| 510k Number | K061918 |
| Device Name: | FOLEY CATHETERS WITH TEMPERATURE PROBE |
| Classification | Catheter, Upper Urinary Tract |
| Applicant | GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Contact | Joel Kent |
| Correspondent | Joel Kent GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Product Code | EYC |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-06 |
| Decision Date | 2006-08-18 |
| Summary: | summary |