The following data is part of a premarket notification filed by Zen Strong Medical Technology Co., Ltd with the FDA for Clinical Thermometer/model Zsdt-xxxx Digital Thermometer And Zset-xxx Infrared Thermometer.
| Device ID | K070578 |
| 510k Number | K070578 |
| Device Name: | CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ZEN STRONG MEDICAL TECHNOLOGY CO., LTD 6F,NO.88 NING JING ST., Keelung,, TW |
| Contact | Cheng Roei-sheng |
| Correspondent | Cheng Roei-sheng ZEN STRONG MEDICAL TECHNOLOGY CO., LTD 6F,NO.88 NING JING ST., Keelung,, TW |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-01 |
| Decision Date | 2007-07-11 |
| Summary: | summary |