FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
DIGITAL ELECTROCARDIOGRAPH
K Number: K132758
·
Decision Jan 30, 2014
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
5
Review Days
148
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Basic Information
- Device Name
- DIGITAL ELECTROCARDIOGRAPH
- K Number
- K132758
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
- Date Received
- September 4, 2013
- Decision Date
- January 30, 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 Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K160092 | Digital Electrocardiograph | Feb 12, 2016 | Substantially Equivalent |
| K152384 | Digital Electrocardiograph | Dec 18, 2015 | Substantially Equivalent |
| K141946 | DIGITAL ELECTROCARDIOGRAPH | Feb 13, 2015 | Substantially Equivalent |
| K133985 | DIGITAL ELECTROCARDIOGRAPH | Jan 22, 2015 | Substantially Equivalent |