Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36
K153149 is the FDA 510(k) clearance record for Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36, a class II device, cleared for Sejoy Electronics & Instruments Co., Ltd. on under FDA product code FLL (Continuous Measurement Thermometer). FDA's definition for product code FLL reads: "A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt...". FDA records list 14 510(k) clearances for Sejoy Electronics & Instruments Co., Ltd., from to . As of , FDA records show no recalls naming K153149.
Clearance record
- Decision date
- Received
- (210 days to decision)
- Product code
- FLL Continuous Measurement Thermometer
- Regulation
- 21 CFR 880.2910
- Device class
- Class II
- Review panel
- General Hospital
- Applicant
- Sejoy Electronics & Instruments Co., Ltd. Bldg. 2, # 202, Zhenzhong Rd., Hang Zhou, CN
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code FLL
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 1 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 1 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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