The following data is part of a premarket notification filed by Shenzhen Jumper Medical Equipment Co., Ltd with the FDA for Non-contact Infrared Thermometer.
| Device ID | K131243 |
| 510k Number | K131243 |
| Device Name: | NON-CONTACT INFRARED THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD 4TH FLOOR, JINHUI BLDG, NANHAI BLVD, NANSHAN DISTRICT Shenzhen, Guangdon, CN 518052 |
| Contact | Field Fu |
| Correspondent | Field Fu SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD 4TH FLOOR, JINHUI BLDG, NANHAI BLVD, NANSHAN DISTRICT Shenzhen, Guangdon, CN 518052 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-01 |
| Decision Date | 2013-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06951740500555 | K131243 | 000 |
| B459SY18220 | K131243 | 000 |
| B459SY18190 | K131243 | 000 |
| B459SY18210 | K131243 | 000 |
| 06943893902003 | K131243 | 000 |
| 06943893902010 | K131243 | 000 |
| 06943893920311 | K131243 | 000 |
| 06951740500081 | K131243 | 000 |
| 06951740500098 | K131243 | 000 |
| 06951740500104 | K131243 | 000 |
| 06951740500111 | K131243 | 000 |
| 06951740500128 | K131243 | 000 |
| 06951740502047 | K131243 | 000 |
| 00682891111104 | K131243 | 000 |
| 08719481720001 | K131243 | 000 |
| 08719481720018 | K131243 | 000 |
| 08719481720148 | K131243 | 000 |
| 08719481720155 | K131243 | 000 |
| 08719481720803 | K131243 | 000 |
| 08719481721022 | K131243 | 000 |
| 08719481721459 | K131243 | 000 |
| 08719481721466 | K131243 | 000 |
| 08719481721503 | K131243 | 000 |
| 00001245890032 | K131243 | 000 |
| 08883000001749 | K131243 | 000 |
| 06951740500135 | K131243 | 000 |
| 06951740500142 | K131243 | 000 |
| 00817746020274 | K131243 | 000 |
| 00817746021325 | K131243 | 000 |
| 00739810202990 | K131243 | 000 |
| 00739810203379 | K131243 | 000 |
| 00739810203515 | K131243 | 000 |
| 00739810203850 | K131243 | 000 |
| 00739810203911 | K131243 | 000 |
| 00667673872824 | K131243 | 000 |
| 00667673872848 | K131243 | 000 |
| 00667673872855 | K131243 | 000 |
| 00616784561332 | K131243 | 000 |
| 00864984000407 | K131243 | 000 |
| 00864243000421 | K131243 | 000 |
| 06951740500234 | K131243 | 000 |
| 06951740500166 | K131243 | 000 |
| 06951740501255 | K131243 | 000 |
| 06951740501644 | K131243 | 000 |
| 06951740501996 | K131243 | 000 |
| 06951740502115 | K131243 | 000 |
| 06951740505215 | K131243 | 000 |
| 06951740545723 | K131243 | 000 |
| 06970596810014 | K131243 | 000 |
| 00863101000313 | K131243 | 000 |
| 00863850000305 | K131243 | 000 |
| 00628055787259 | K131243 | 000 |