FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRESSURE FUNCTION BLOCKS
K Number: K810172
·
Decision Feb 25, 1981
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
76
Applicant Total
69
Review Days
34
Basic Information
- Device Name
- PRESSURE FUNCTION BLOCKS
- K Number
- K810172
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1110
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- HONEYWELL, INC.
- Date Received
- January 22, 1981
- Decision Date
- February 25, 1981
- 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 HONEYWELL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K902230 | COLORADO COLOR IMAGING RECORDER | Jun 19, 1990 | Substantially Equivalent |
| K863100 | CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR | Feb 3, 1987 | Substantially Equivalent |
| K853501 | HONEYWELL ELECTRONIC VENTILATOR EV-A | Apr 4, 1986 | Substantially Equivalent |
| K855125 | PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM | Mar 26, 1986 | Substantially Equivalent |
| K851888 | APM DISPOS. BLOOD PRESSURE TRANSDUCER | Aug 6, 1985 | Substantially Equivalent |
| K851496 | ECG MONITOR MODEL RM102 | Jul 24, 1985 | Substantially Equivalent |
| K850794 | PATIENT MONITOR MODEL RM-300 | Apr 18, 1985 | Substantially Equivalent |
| K851092 | PORTABLE DEFIBRILLATOR/MONITOR ED 425 | Apr 10, 1985 | Substantially Equivalent |
| K834530 | EXTENSION BOX EB200 | Jun 1, 1984 | Substantially Equivalent |
| K834282 | ULTRA IMAGER 2000 | Apr 23, 1984 | Substantially Equivalent |