FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EPICARIDA, LE
K Number: K872837
·
Decision Nov 4, 1987
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
23
Review Days
107
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Basic Information
- Device Name
- EPICARIDA, LE
- K Number
- K872837
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medicomp, Inc.
- Date Received
- July 20, 1987
- Decision Date
- November 4, 1987
- 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 Medicomp, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K173170 | Epicardia Anywhere | Jan 10, 2018 | Substantially Equivalent |
| K161916 | TelePatch Cardiac Monitor | Dec 21, 2016 | Substantially Equivalent |
| K091696 | SAVI WIRELESS, MODEL PM500 | Oct 26, 2009 | Substantially Equivalent |
| K090834 | EPICARDIA 5000 | May 15, 2009 | Substantially Equivalent |
| K043454 | CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 | Mar 24, 2005 | Substantially Equivalent |
| K981119 | CARDIOPAL MODEL NUMBER PM20 | Oct 14, 1998 | Substantially Equivalent |
| K952846 | EPICARDIA | Sep 18, 1995 | Substantially Equivalent |
| K943915 | HEAT AND MOISTURE EXCHANGER FILTER (HME) | Oct 14, 1994 | Substantially Equivalent |
| K900207 | EPICARDIA 4000 | Jul 31, 1990 | Substantially Equivalent |
| K883103 | EPICARDIA PC/FC | Sep 22, 1988 | Substantially Equivalent |