The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Tympanic Temperature Probe With Foam, Model M1024233; Without Foam Model M1024237.
Device ID | K061942 |
510k Number | K061942 |
Device Name: | TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237 |
Classification | Thermometer, Electronic, Clinical |
Applicant | GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
Contact | Joel C Kent |
Correspondent | Joel C Kent GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-07-10 |
Decision Date | 2006-09-29 |
Summary: | summary |