FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMEGA 5000
K Number: K833978
·
Decision Mar 9, 1984
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
5
Review Days
113
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OMEGA 5000
- K Number
- K833978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Invivo Research Labs, Inc.
- Date Received
- November 17, 1983
- Decision Date
- March 9, 1984
- Product Code
- DXN
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXN), ordered by most recent decision date.
Wrist Blood Pressure Monitor (XW-05)
FDA 510(k)
FDA Class 2
·Cardiovascular
VicorderCS (VCS-SYS-1100)
FDA 510(k)
FDA Class 2
·Cardiovascular
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
FDA 510(k)
FDA Class 2
·Cardiovascular
Upper arm electronic blood pressure monitor (XB-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
Blood Pressure Monitor (W06LT)
FDA 510(k)
FDA Class 2
·Cardiovascular
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
FDA 510(k)
FDA Class 2
·Cardiovascular