FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DR-2C
K Number: K844650
·
Decision Jan 22, 1985
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
77
Applicant Total
13
Review Days
54
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
- DR-2C
- K Number
- K844650
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- General Devices
- Date Received
- November 29, 1984
- Decision Date
- January 22, 1985
- Product Code
- DXJ
- 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 |
|---|---|---|---|
| DXJ | Display, Cathode-Ray Tube, Medical | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXJ), ordered by most recent decision date.
ESSENZ Patient Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
Philips IntelliVue GuardianSoftware (Rev. E.0X)
FDA 510(k)
FDA Class 2
·Cardiovascular
Essence 55SP Large Monitor System
FDA 510(k)
FDA Class 2
·Cardiovascular
Vios Central Station Monitor Software, Vios Central Server Software
FDA 510(k)
FDA Class 2
·Cardiovascular
Philips IntelliVue GuardianSoftware
FDA 510(k)
FDA Class 2
·Cardiovascular
Nexxis OR
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by General Devices
| K Number | Device Name | ||
|---|---|---|---|
| K013533 | EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) | Jan 18, 2002 | Substantially Equivalent |
| K002089 | ROSETTA-LT/ROSETTA-RX | Nov 21, 2000 | Substantially Equivalent |
| K993202 | EIM-107 PREP-CHECK | Dec 17, 1999 | Substantially Equivalent |
| K940009 | GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 | Apr 14, 1995 | Substantially Equivalent |
| K935839 | GEMSCOM SERIES 5000, | Nov 10, 1994 | Substantially Equivalent |
| K921929 | GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) | Sep 18, 1992 | Substantially Equivalent |
| K914889 | GEMSCOM SERIES 3000 | Mar 4, 1992 | Substantially Equivalent |
| K912008 | TRU-VIEW MULTI-CHANNEL DISPLAY | Oct 9, 1991 | Substantially Equivalent |
| K896153 | MODIFIED DR-2C/PMC 100 | Jan 19, 1990 | Substantially Equivalent |
| K862596 | DR-2C (MODIFICATION) | Sep 26, 1986 | Substantially Equivalent |