FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
K Number: K011980
·
Decision Sep 12, 2001
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
19
Review Days
79
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Basic Information
- Device Name
- ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
- K Number
- K011980
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pace Medical
- Date Received
- June 25, 2001
- Decision Date
- September 12, 2001
- 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 Pace Medical
| K Number | Device Name | ||
|---|---|---|---|
| K012392 | DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 | Sep 4, 2001 | Substantially Equivalent |
| K002204 | PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V | Oct 18, 2000 | Substantially Equivalent |
| K002497 | MODEL 4810 ANALYZER OUTPUT ADAPTER | Oct 10, 2000 | Substantially Equivalent |
| K002496 | MODEL 4815 ADAPTER | Oct 10, 2000 | Substantially Equivalent |
| K001180 | TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 | Jun 27, 2000 | Substantially Equivalent |
| K925143 | MODEL 4800 ACCUPACE PACING SYSTEM ANALYER | Sep 27, 1994 | Substantially Equivalent |
| K931662 | LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES | Aug 31, 1993 | Substantially Equivalent |
| K922899 | MODEL 4280 SURGICAL EXTENSION CABLE | Dec 23, 1992 | Substantially Equivalent |
| K913805 | MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER | Nov 19, 1991 | Substantially Equivalent |
| K913134 | MODEL 4220 | Aug 22, 1991 | Substantially Equivalent |