FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
DLM112 DAYLINK MONITOR
K Number: K062304
·
Decision Sep 29, 2006
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
190
Applicant Total
3
Review Days
52
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Basic Information
- Device Name
- DLM112 DAYLINK MONITOR
- K Number
- K062304
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2910
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rtx Healthcare A/S
- Date Received
- August 8, 2006
- Decision Date
- September 29, 2006
- Product Code
- DRG
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | FDA class 2 | Cardiovascular |
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