FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620
K Number: K874339
·
Decision Dec 18, 1987
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
76
Applicant Total
34
Review Days
58
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Basic Information
- Device Name
- TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620
- K Number
- K874339
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1110
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- A&D Engineering, Inc.
- Date Received
- October 21, 1987
- Decision Date
- December 18, 1987
- Product Code
- DSK
- 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 |
|---|---|---|---|
| DSK | Computer, Blood-Pressure | FDA class 2 | Cardiovascular |
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Other Clearances by A&D Engineering, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082734 | A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR | Nov 13, 2008 | Substantially Equivalent |
| K062027 | A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR | Jan 19, 2007 | Substantially Equivalent |
| K061456 | A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR | Jun 21, 2006 | Substantially Equivalent |
| K043217 | A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR | Mar 3, 2005 | Substantially Equivalent |
| K042967 | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 | Dec 3, 2004 | Substantially Equivalent |
| K040371 | A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR | May 19, 2004 | Substantially Equivalent |
| K040229 | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328 | Mar 19, 2004 | Substantially Equivalent |
| K032499 | A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS | Oct 30, 2003 | Substantially Equivalent |
| K012472 | A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS | Feb 15, 2002 | Substantially Equivalent |
| K012013 | LIFESOURCE MODELS UA-787, UA 787PC, UA-787T | Jul 13, 2001 | Substantially Equivalent |