FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
PACEMAKERS, VITATRONS (SERIES 2000)
K Number: K760670
·
Decision Nov 12, 1976
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
460
Applicant Total
19
Review Days
56
Basic Information
- Device Name
- PACEMAKERS, VITATRONS (SERIES 2000)
- K Number
- K760670
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- VITATRON MEDICAL BV
- Date Received
- September 17, 1976
- Decision Date
- November 12, 1976
- Product Code
- DXY
- 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 |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | FDA class 3 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXY), ordered by most recent decision date.
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
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MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
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NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
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Other Clearances by VITATRON MEDICAL BV
| K Number | Device Name | ||
|---|---|---|---|
| K854790 | CERYX PACEMAKER MODELS 114, 314 & 614 | Aug 28, 1986 | Substantially Equivalent |
| K844484 | HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA | Jul 24, 1985 | Substantially Equivalent |
| K844485 | CERYX6, 611, CERYX 3 311 & CERYX 1 111 | Apr 19, 1985 | Substantially Equivalent |
| K844483 | TP 1 | Apr 19, 1985 | Substantially Equivalent |
| K840668 | ELECTRODE PACEMAKER, PERM & TEMP | Sep 24, 1984 | Substantially Equivalent |
| K831860 | GENERATOR, PULSE, PACEMAKER #532 | Oct 27, 1983 | Substantially Equivalent |
| K831859 | PACEMAKER PROGRAMMER #2032 | Oct 27, 1983 | Substantially Equivalent |
| K810928 | ENDOCARDIAL ELECTRODE | Jul 2, 1981 | Substantially Equivalent |
| K791920 | CARDIAC PACEMAKER P4000 SER. & P1000 | Nov 29, 1979 | Substantially Equivalent |
| K791921 | CARDIAC PACEMAKER C4000, C1000 SER. | Oct 26, 1979 | Substantially Equivalent |