FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NETLINK/NETSCAN
K Number: K020213
·
Decision Apr 5, 2002
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
6
Review Days
73
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Basic Information
- Device Name
- NETLINK/NETSCAN
- K Number
- K020213
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rozinn Electronics, Inc.
- Date Received
- January 22, 2002
- Decision Date
- April 5, 2002
- Product Code
- DXH
- 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | FDA class 2 | Cardiovascular |
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Other Clearances by Rozinn Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K061780 | TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + | Sep 15, 2006 | Substantially Equivalent |
| K042463 | HOLTER PLUS | Sep 22, 2004 | Substantially Equivalent |
| K022540 | CARDIO ID+(RZ153+) | Oct 24, 2002 | Substantially Equivalent |
| K021517 | ABP FOR WINDOWS | Jul 24, 2002 | Substantially Equivalent |
| K903331 | ROZINN 151 | Oct 22, 1990 | Substantially Equivalent |