FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COPAL DIGITAL THERMOMETER UF-12
K Number: K850195
·
Decision Feb 7, 1985
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
11
Review Days
20
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Basic Information
- Device Name
- COPAL DIGITAL THERMOMETER UF-12
- K Number
- K850195
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Takeda Medical, Inc.
- Date Received
- January 18, 1985
- Decision Date
- February 7, 1985
- 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 Takeda Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K854797 | TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-731 | May 9, 1986 | Substantially Equivalent |
| K853158 | DIGITAL SPHYGMOMANOMETER MODEL 7620 | Nov 14, 1985 | Substantially Equivalent |
| K851223 | COPAL DIGITAL SPHYGMOMANOMETER UA-560 | Sep 9, 1985 | Substantially Equivalent |
| K852564 | COPAL UA-512 DIGITAL BLOOD PRESSURE MONITOR | Aug 19, 1985 | Substantially Equivalent |
| K843390 | COPAL DIGITAL SPHYGMOMANOMETER UA-535 | May 15, 1985 | Substantially Equivalent |
| K844285 | COPAL DIGITAL SPHYGMOMAMOMETER UA-550 | Apr 18, 1985 | Substantially Equivalent |
| K842388 | COPAL DIGITAL SPHYGMOMANOMETER UA-510 | Feb 13, 1985 | Substantially Equivalent |
| K844284 | COPAL DIGITAL SPHYGMOMANOMETER UA-540 | Feb 8, 1985 | Substantially Equivalent |
| K850196 | COPAL DIGITAL THERMOMETER UF-22B | Feb 7, 1985 | Substantially Equivalent |
| K843040 | COPAL DIGITAL THERMOMETER UF-10 | Jan 3, 1985 | Substantially Equivalent |