The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Kejump Digital Clinical Thermometer.
Device ID | K903590 |
510k Number | K903590 |
Device Name: | KEJUMP DIGITAL CLINICAL THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | K-JUMP HEALTH CO., LTD. 26792 VIA ALCALA Mission Viejo, CA 92691 |
Contact | Phillip J Zulueta |
Correspondent | Phillip J Zulueta K-JUMP HEALTH CO., LTD. 26792 VIA ALCALA Mission Viejo, CA 92691 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-08 |
Decision Date | 1990-10-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00614801400534 | K903590 | 000 |
00614801300513 | K903590 | 000 |
20614801300104 | K903590 | 000 |
20665973017093 | K903590 | 000 |
20665973017086 | K903590 | 000 |
10326053105019 | K903590 | 000 |