FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTION 301 PACEMAKER EVAL. MODULE MAC-1
K Number: K802368
·
Decision Mar 4, 1981
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
82
Review Days
156
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Basic Information
- Device Name
- OPTION 301 PACEMAKER EVAL. MODULE MAC-1
- K Number
- K802368
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Marquette Electronics, Inc.
- Date Received
- September 29, 1980
- Decision Date
- March 4, 1981
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 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 |
| K962827 | ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) | Feb 24, 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 |