FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE
K Number: K020896
·
Decision Jun 14, 2002
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
64
Applicant Total
7
Review Days
87
Basic Information
- Device Name
- OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE
- K Number
- K020896
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OSYPKA MEDICAL, INC.
- Date Received
- March 19, 2002
- Decision Date
- June 14, 2002
- 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 OSYPKA MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K123916 | PSA SERIES | Apr 9, 2013 | Unknown |
| K082242 | ICON, MODEL C3 | Oct 8, 2008 | Substantially Equivalent |
| K081035 | AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 | May 30, 2008 | Substantially Equivalent |
| K070985 | AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC | Feb 1, 2008 | Substantially Equivalent |
| K033130 | PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR | Oct 31, 2003 | Substantially Equivalent |
| K022939 | OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES | Oct 3, 2002 | Substantially Equivalent |