FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROPAQ 104(TM)
K Number: K882085
·
Decision Jul 28, 1988
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
76
Applicant Total
15
Review Days
71
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
- PROPAQ 104(TM)
- K Number
- K882085
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1110
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Protocol Systems, Inc.
- Date Received
- May 18, 1988
- Decision Date
- July 28, 1988
- 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 Protocol Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002725 | MICROPAQ, MODELS 402 AND 404 | Nov 21, 2000 | Substantially Equivalent |
| K972121 | ACUITY CENTRAL STATION | Nov 7, 1997 | Substantially Equivalent |
| K951246 | PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS | Feb 2, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K945071 | PROPAQ 200 MONITOR | May 10, 1995 | Substantially Equivalent |
| K935846 | MODEL ACUITY CENTRAL STATION | Dec 5, 1994 | Substantially Equivalent |
| K934711 | PROPAQ ECG TELEMETRY OPTION | Sep 1, 1994 | Substantially Equivalent |
| K921497 | PROPAQ MONITORS, MODIFICATION | Mar 23, 1993 | Substantially Equivalent |
| K914838 | PROPAQ 102,104,106,102EL,104EL,&106EL | Jan 10, 1992 | Substantially Equivalent |
| K913193 | MODEL 100 CENTRAL STATION | Oct 16, 1991 | Substantially Equivalent |
| K910882 | PROPAQ 102EL, 104EL AND 106EL | May 8, 1991 | Substantially Equivalent |