FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEM ACCESSORY FOR EPI CARDIA SYS
K Number: K834034
·
Decision May 9, 1984
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
23
Review Days
168
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Basic Information
- Device Name
- MODEM ACCESSORY FOR EPI CARDIA SYS
- K Number
- K834034
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medicomp, Inc.
- Date Received
- November 23, 1983
- Decision Date
- May 9, 1984
- Product Code
- DXH
- 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| 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 |