The following data is part of a premarket notification filed by Ech (changzhou) Medical Instrument Co., Ltd. with the FDA for Wireless Thermometer.
| Device ID | K170769 |
| 510k Number | K170769 |
| Device Name: | Wireless Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ECH (Changzhou) Medical Instrument Co., Ltd. No.65, Huiling West Rd. Zouqu Town Changzhou, CN 213144 |
| Contact | Yuan Hu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd Room 405, Ziguang Mansion No.341 Shangcheng Road Shanghai, CN 200120 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-14 |
| Decision Date | 2017-07-26 |
| Summary: | summary |