FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)
K Number: K962827
·
Decision Feb 24, 1997
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
82
Review Days
220
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Basic Information
- Device Name
- ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)
- K Number
- K962827
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Marquette Electronics, Inc.
- Date Received
- July 19, 1996
- Decision Date
- February 24, 1997
- 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 Marquette Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971868 | IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM | Nov 13, 1997 | Substantially Equivalent |
| K971683 | WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET | Oct 22, 1997 | Substantially Equivalent |
| K972199 | SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS | Sep 25, 1997 | Substantially Equivalent |
| K962547 | CARDIOSERV P | Mar 6, 1997 | Substantially Equivalent |
| K963120 | RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM | Feb 28, 1997 | Substantially Equivalent |
| K964750 | EAGLE 4000 PATIENT MONITOR | Feb 21, 1997 | Substantially Equivalent |
| K962551 | CARDIOSERV S | Nov 19, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K960418 | EAGLE PATIENT MONITOR | Oct 2, 1996 | Substantially Equivalent |
| K960272 | EAGLE 3000/3100 PATIENT MONITOR | Oct 2, 1996 | Substantially Equivalent |
| K961139 | EAGLE PATIENT MONITOR MODEL 3000/3100 | Aug 9, 1996 | Substantially Equivalent |