FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
RTX3320PSTN WIRELESS TELEHEALTH GATEWAY
K Number: K041816
·
Decision Jul 19, 2004
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
190
Applicant Total
3
Review Days
13
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Basic Information
- Device Name
- RTX3320PSTN WIRELESS TELEHEALTH GATEWAY
- K Number
- K041816
- 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
- July 6, 2004
- Decision Date
- July 19, 2004
- 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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