FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DINAMAP MODEL 848
K Number: K781064
·
Decision Sep 7, 1978
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
76
Applicant Total
22
Review Days
73
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
- DINAMAP MODEL 848
- K Number
- K781064
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1110
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Applied Medical Research
- Date Received
- June 26, 1978
- Decision Date
- September 7, 1978
- Product Code
- DSK
- 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 |
|---|---|---|---|
| DSK | Computer, Blood-Pressure | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSK), ordered by most recent decision date.
Endophys Blood Pressure Monitor model BPM-30
FDA 510(k)
FDA Class 2
·Cardiovascular
Endophys Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOPHYS BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Applied Medical Research
| K Number | Device Name | ||
|---|---|---|---|
| K800025 | DINAMAP RESEARCH MONITOR 1245 | Feb 1, 1980 | Substantially Equivalent |
| K791580 | CEREBRAL FUNCTION MONITOR 870 | Sep 4, 1979 | Substantially Equivalent |
| K791159 | DINAMAP MODEL 855 | Jul 30, 1979 | Substantially Equivalent |
| K790322 | OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 | May 14, 1979 | Substantially Equivalent |
| K790328 | MODEL 1051, MONITOR | Mar 2, 1979 | Substantially Equivalent |
| K782073 | DINAMAP MODELS 1160 AND 1165 | Feb 23, 1979 | Substantially Equivalent |
| K781053 | DINAMAP MODEL 846 | Sep 7, 1978 | Substantially Equivalent |
| K781311 | ELECTRODE, NEEDLE, CFM | Aug 21, 1978 | Substantially Equivalent |
| K780754 | NEONATAL MONITOR | Jun 14, 1978 | Substantially Equivalent |
| K780759 | MODEL 902 STAND | May 19, 1978 | Substantially Equivalent |