The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Non-contact Infrared Thermometer.
| Device ID | K102947 |
| 510k Number | K102947 |
| Device Name: | NON-CONTACT INFRARED THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., WU KU INDUSTRIAL PARK Taipei Hsien, TW 248 |
| Contact | Jason Cheng |
| Correspondent | Jason Cheng K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., WU KU INDUSTRIAL PARK Taipei Hsien, TW 248 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-04 |
| Decision Date | 2011-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634782597443 | K102947 | 000 |