The following data is part of a premarket notification filed by Shenzhen Calibeur Industries Co., Ltd. with the FDA for Infared Thermometer.
Device ID | K191251 |
510k Number | K191251 |
Device Name: | Infared Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | Shenzhen Calibeur Industries Co., Ltd. No. 11 Bldg., Shiguan Industrial Park, Gongming, Guangming New District Shenzhen, CN |
Contact | Weibin He |
Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District Shenzhen, CN 518067 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-05-09 |
Decision Date | 2019-10-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06970000910828 | K191251 | 000 |
00810477022852 | K191251 | 000 |
00810477022838 | K191251 | 000 |
00810477023668 | K191251 | 000 |
00810477023606 | K191251 | 000 |
00810477023613 | K191251 | 000 |
00810477022869 | K191251 | 000 |
00810477022883 | K191251 | 000 |
00810477021749 | K191251 | 000 |
06970000910132 | K191251 | 000 |
06970000910170 | K191251 | 000 |
06970000910811 | K191251 | 000 |
00810477022876 | K191251 | 000 |