FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PACEART CARDIOVOICE
K Number: K952065
·
Decision Jan 16, 1996
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
9
Review Days
259
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Basic Information
- Device Name
- PACEART CARDIOVOICE
- K Number
- K952065
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paceart, Inc.
- Date Received
- May 2, 1995
- Decision Date
- January 16, 1996
- 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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Other Clearances by Paceart, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012407 | PACEART TX3 CARDIAC EVENT RECORDER | Aug 14, 2001 | Substantially Equivalent |
| K982090 | PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM | Jan 26, 1999 | Substantially Equivalent |
| K973141 | HEART ACCESS PLUS CARDIAC EVENT RECORDER | Nov 12, 1997 | Substantially Equivalent |
| K960721 | PACEART WRIST ELECTRODES | Jul 18, 1996 | Substantially Equivalent |
| K931296 | PACEART CARDIOPHONE | Oct 1, 1993 | Substantially Equivalent |
| K915632 | PACEART CPTS-86/12 | Apr 14, 1992 | Substantially Equivalent |
| K880283 | PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS | Mar 9, 1988 | Substantially Equivalent |
| K870909 | PACEMAKER FUNCTION ANALYZER | Apr 27, 1987 | Substantially Equivalent |