FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
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
K Number: K153149
·
Decision May 27, 2016
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
14
Review Days
210
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Basic Information
- Device Name
- 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
- K Number
- K153149
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sejoy Electronics & Instruments Co., Ltd.
- Date Received
- October 30, 2015
- Decision Date
- May 27, 2016
- Product Code
- FLL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | FDA class 2 | General Hospital |
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Other Clearances by Sejoy Electronics & Instruments Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K161577 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | Feb 8, 2017 | Substantially Equivalent |
| K153146 | Infrared Ear Thermometer | Mar 31, 2016 | Substantially Equivalent |
| K152426 | Wrist - Type Fully Automatic Digital Blood Pressure Monitor | Nov 9, 2015 | Substantially Equivalent |
| K152687 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | Oct 16, 2015 | Substantially Equivalent |
| K150545 | Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) | Apr 2, 2015 | Substantially Equivalent |
| K141755 | ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | Nov 19, 2014 | Substantially Equivalent |
| K120554 | ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | Aug 10, 2012 | Substantially Equivalent |
| K121355 | WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | Jul 18, 2012 | Substantially Equivalent |
| K110776 | DIGITAL THERMOMETER MT SERIES | Aug 24, 2011 | Substantially Equivalent |
| K082192 | INFRARED EAR THERMOMETER, MODEL ET-101A | Sep 17, 2008 | Substantially Equivalent |