The following data is part of a premarket notification filed by Cotronic Manufacturing with the FDA for Clinical Electronic Thermometer.
Device ID | K032434 |
510k Number | K032434 |
Device Name: | CLINICAL ELECTRONIC THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | COTRONIC MANUFACTURING JIU WEI, XI XIANG BAO AN ZONE Shen Zhen, CN |
Contact | Shine Wan |
Correspondent | Shine Wan COTRONIC MANUFACTURING JIU WEI, XI XIANG BAO AN ZONE Shen Zhen, CN |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-06 |
Decision Date | 2004-12-27 |
Summary: | summary |