FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EPICARDIA
K Number: K952846
·
Decision Sep 18, 1995
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
23
Review Days
89
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Basic Information
- Device Name
- EPICARDIA
- K Number
- K952846
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicomp, Inc.
- Date Received
- June 21, 1995
- Decision Date
- September 18, 1995
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 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 |
| 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 |
| K881770 | EPICARDIA LE/FD | May 31, 1988 | Substantially Equivalent |