FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
CheckMyHeart Plus
K Number: K172778
·
Decision Jul 5, 2018
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
5
Review Days
294
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Basic Information
- Device Name
- CheckMyHeart Plus
- K Number
- K172778
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dailycare Biomedical, Inc.
- Date Received
- September 14, 2017
- Decision Date
- July 5, 2018
- 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 Dailycare Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K062894 | INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 | Feb 8, 2007 | Substantially Equivalent |
| K052303 | READMYHEART, MODEL RMH2.0 | Dec 16, 2005 | Substantially Equivalent |
| K050620 | READMYHEART, MODEL RMH3.0 | Jul 14, 2005 | Substantially Equivalent |
| K042814 | READMYHEART | Jan 6, 2005 | Substantially Equivalent |