FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ERA-20
K Number: K853194
·
Decision Mar 11, 1987
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
41
Review Days
589
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Basic Information
- Device Name
- ERA-20
- K Number
- K853194
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Biotronik Sales, Inc.
- Date Received
- July 30, 1985
- Decision Date
- March 11, 1987
- 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 |
Similar 510(k) Clearances
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Lifetech Cardio Model 8301 Temporary Pacemaker
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Medtronic Model 5392 External Pulse Generator (EPG)
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Other Clearances by Biotronik Sales, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K875199 | NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR | Feb 18, 1988 | Substantially Equivalent |
| K860036 | EDP-20 PACEMAKER | Jan 12, 1987 | Substantially Equivalent |
| K863879 | NEOS-M VS-1 PULSE GENERATOR | Dec 10, 1986 | Substantially Equivalent |
| K863878 | TRIOS-M VS-1 PULSE GENERATOR | Dec 10, 1986 | Substantially Equivalent |
| K863480 | BIOTRONIK PERMANENT PACEMAKER ELECTRODE | Sep 23, 1986 | Substantially Equivalent |
| K860921 | NEOS VS-1, PULSE GENERATOR | Aug 8, 1986 | Substantially Equivalent |
| K860922 | MIKROS, MIKROS VS-1, PULSE GENERATOR | Aug 4, 1986 | Substantially Equivalent |
| K853567 | DJP UNIPOLAR | May 7, 1986 | Substantially Equivalent |
| K853566 | DJ UNIPOLAR | May 7, 1986 | Substantially Equivalent |
| K853568 | DNR UNIPOLAR | Jan 15, 1986 | Substantially Equivalent |