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 |