FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTERNAL DEMAND PACEMAKER
K Number: K923621
·
Decision May 19, 1993
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
31
Review Days
302
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Basic Information
- Device Name
- EXTERNAL DEMAND PACEMAKER
- K Number
- K923621
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Oscor Medical Corp.
- Date Received
- July 21, 1992
- Decision Date
- May 19, 1993
- 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 Oscor Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K964107 | OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR | Apr 1, 1997 | Substantially Equivalent - Subject to Tracking & PMS |
| K925168 | MISCELLANEOUS PACING LEAD | May 3, 1994 | Substantially Equivalent |
| K912867 | OSCOR MEDICAL CORP PERMANENT PACING LEAD | Feb 4, 1992 | Substantially Equivalent |
| K915007 | PERMANENT PACING LEADS, MODIFICATION | Jan 27, 1992 | Substantially Equivalent |
| K915008 | PERMANENT PACING PAD, MODIFICATION | Jan 27, 1992 | Substantially Equivalent |
| K913204 | MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION | Sep 23, 1991 | Substantially Equivalent |
| K913158 | MODIFIED OSCOR PY PACING LEADS/MODIFICATION | Sep 23, 1991 | Substantially Equivalent |
| K913202 | IMPLANT PACING LEAD, TINED #3262, MODIFICATION | Sep 23, 1991 | Substantially Equivalent |
| K913203 | IMPLANT PACING LEAD TINED #3390, MODIFICATION | Sep 23, 1991 | Substantially Equivalent |
| K913201 | PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION | Sep 23, 1991 | Substantially Equivalent |