FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0
K Number: K062894
·
Decision Feb 8, 2007
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
5
Review Days
134
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Basic Information
- Device Name
- INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0
- K Number
- K062894
- 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 27, 2006
- Decision Date
- February 8, 2007
- 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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