The following data is part of a premarket notification filed by Y with the FDA for Model 2082 Temp Plus Iii Thermometer/model 2087 Temp Plus Iii Wall Mount Thermometer.
Device ID | K955846 |
510k Number | K955846 |
Device Name: | MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | Y 10300 CAMPUS POINT DR. San Diego, CA 92121 -1579 |
Contact | Jennifer S Hankard |
Correspondent | Jennifer S Hankard Y 10300 CAMPUS POINT DR. San Diego, CA 92121 -1579 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-26 |
Decision Date | 1996-10-01 |
Summary: | summary |