FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
READMYHEART
K Number: K042814
·
Decision Jan 6, 2005
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
5
Review Days
86
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Basic Information
- Device Name
- READMYHEART
- K Number
- K042814
- 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
- October 12, 2004
- Decision Date
- January 6, 2005
- 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 | ||
|---|---|---|---|
| K172778 | CheckMyHeart Plus | Jul 5, 2018 | Substantially Equivalent |
| 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 |