FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
ENERTRAX MODEL 7100E
K Number: K822297
·
Decision Oct 4, 1982
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
460
Applicant Total
468
Review Days
62
Basic Information
- Device Name
- ENERTRAX MODEL 7100E
- K Number
- K822297
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- MEDTRONIC VASCULAR
- Date Received
- August 3, 1982
- Decision Date
- October 4, 1982
- 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 |
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|---|---|---|---|
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| K081573 | MEDTRONIC EXPORT AP CATHETER | Jun 27, 2008 | Substantially Equivalent |