FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTERNAL PULSE GENERATOR - EV4542
K Number: K821791
·
Decision Jul 6, 1982
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
14
Review Days
19
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Basic Information
- Device Name
- EXTERNAL PULSE GENERATOR - EV4542
- K Number
- K821791
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- American Pacemaker Corp.
- Date Received
- June 17, 1982
- Decision Date
- July 6, 1982
- Product Code
- DTE
- 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 |
|---|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | FDA class 2 | Cardiovascular |
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Other Clearances by American Pacemaker Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K812830 | APC IMPLANTABLE PACING LEAD | Jan 18, 1982 | Substantially Equivalent |
| K812807 | APC IMPLANTABLE PACING LEADS | Jan 18, 1982 | Substantially Equivalent |
| K810397 | APC IMPLANTABLE PACING LEAD-FLANGE #3260 | May 15, 1981 | Substantially Equivalent |
| K810396 | APC IMPLANTABLE PACING LEAD, TINED #3262 | May 15, 1981 | Substantially Equivalent |
| K810398 | APC IMPLANTABLE PACING LEAD, MODEL 3266 | May 15, 1981 | Substantially Equivalent |
| K810399 | APC IMPLANTABEL PACING LEAD, MODEL 3264 | May 15, 1981 | Substantially Equivalent |
| K810121 | UNIFOCAL 3 | Feb 23, 1981 | Substantially Equivalent |
| K800746 | UNIFOCAL VP, MODELS 7501 AND 7502 | Dec 16, 1980 | Substantially Equivalent |
| K800379 | BIFOCAL 2 8200 SERIES (A,B C,D) | Sep 26, 1980 | Substantially Equivalent |
| K791955 | UNIFOCAL 1 UNIPOLAR DEMAND R WAVE | Nov 27, 1979 | Substantially Equivalent |