FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITAL SPHYGMOMANOMETER MODEL 7620
K Number: K853158
·
Decision Nov 14, 1985
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
11
Review Days
107
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Basic Information
- Device Name
- DIGITAL SPHYGMOMANOMETER MODEL 7620
- K Number
- K853158
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Takeda Medical, Inc.
- Date Received
- July 30, 1985
- Decision Date
- November 14, 1985
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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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 |
| 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 |
| K850195 | COPAL DIGITAL THERMOMETER UF-12 | Feb 7, 1985 | Substantially Equivalent |
| K843040 | COPAL DIGITAL THERMOMETER UF-10 | Jan 3, 1985 | Substantially Equivalent |