FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
K Number: K002061
·
Decision Jan 19, 2001
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
34
Review Days
197
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Basic Information
- Device Name
- A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
- K Number
- K002061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- A&D Engineering, Inc.
- Date Received
- July 6, 2000
- Decision Date
- January 19, 2001
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| 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 |