FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROZINN 151
K Number: K903331
·
Decision Oct 22, 1990
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
6
Review Days
89
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Basic Information
- Device Name
- ROZINN 151
- K Number
- K903331
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Rozinn Electronics, Inc.
- Date Received
- July 25, 1990
- Decision Date
- October 22, 1990
- Product Code
- DSH
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 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 |
| K020213 | NETLINK/NETSCAN | Apr 5, 2002 | Substantially Equivalent |