FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL ACUITY CENTRAL STATION
K Number: K935846
·
Decision Dec 5, 1994
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
15
Review Days
362
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Basic Information
- Device Name
- MODEL ACUITY CENTRAL STATION
- K Number
- K935846
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Protocol Systems, Inc.
- Date Received
- December 8, 1993
- Decision Date
- December 5, 1994
- Product Code
- DSI
- 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
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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 |
| 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 |
| K910772 | PROPAQ 102, 104 AND 106 | Apr 12, 1991 | Substantially Equivalent |