The following data is part of a premarket notification filed by Raling Medical Company with the FDA for Wireless Thermometer.
Device ID | K121696 |
510k Number | K121696 |
Device Name: | WIRELESS THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | RALING MEDICAL COMPANY NO. 11, HUATONG RD Beijing, CN 102200 |
Contact | Wu Wei |
Correspondent | Wu Wei RALING MEDICAL COMPANY NO. 11, HUATONG RD Beijing, CN 102200 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-07 |
Decision Date | 2012-10-11 |
Summary: | summary |