FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ERA 3000 PACING SYSTEM ANALYZER
K Number: K042708
·
Decision Oct 20, 2004
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
85
Review Days
20
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Basic Information
- Device Name
- ERA 3000 PACING SYSTEM ANALYZER
- K Number
- K042708
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biotronik, Inc.
- Date Received
- September 30, 2004
- Decision Date
- October 20, 2004
- 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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