FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
MAC 800 Resting ECG Analysis System
K Number: K142288
·
Decision Dec 3, 2014
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
12
Review Days
107
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Basic Information
- Device Name
- MAC 800 Resting ECG Analysis System
- K Number
- K142288
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Medical Systems China Co., Ltd.
- Date Received
- August 18, 2014
- Decision Date
- December 3, 2014
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by Ge Medical Systems China Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K151063 | Monitor B40 | Dec 15, 2015 | Substantially Equivalent |
| K133576 | MONITOR B40 | Feb 21, 2014 | Substantially Equivalent |
| K130584 | MONITOR B40 | Jun 26, 2013 | Substantially Equivalent |
| K122253 | PROCARE MONITOR B20 | Mar 22, 2013 | Substantially Equivalent |
| K123238 | ACHILLES | Feb 25, 2013 | Substantially Equivalent |
| K120598 | PROCARE MONITOR B40 | Jul 19, 2012 | Substantially Equivalent |
| K103633 | ACHILLES | May 11, 2011 | Substantially Equivalent |
| K102256 | GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND | Oct 5, 2010 | Substantially Equivalent |
| K102113 | GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND | Aug 12, 2010 | Substantially Equivalent |
| K091374 | GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND | May 26, 2009 | Substantially Equivalent |