The following data is part of a premarket notification filed by Pinghu Sama Medical Packing Co., Ltd. with the FDA for Disposable Thermometer Probe Sheaths.
| Device ID | K152690 |
| 510k Number | K152690 |
| Device Name: | DISPOSABLE THERMOMETER PROBE SHEATHS |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | PINGHU SAMA MEDICAL PACKING CO., LTD. 1 QUNFENG ROAD SOUTH OF LINDAI Pinghu, CN 314202 |
| Contact | Ma Jianzhong |
| Correspondent | Ray Wang BEIJING BELIEVE TECH. SERVICE CO., LTD. 1-202, BUILD 3, BEIJING NEW WORLD NO.5 CHAOGYANG RD., CHAOGYANG DISTRICT Beijing, CN 100024 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-21 |
| Decision Date | 2016-01-15 |
| Summary: | summary |