FDA 510(k)
FDA class 3
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
HT, MODEL HT PB
K Number: K990142
·
Decision Jul 30, 1999
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
2
Review Days
192
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Basic Information
- Device Name
- HT, MODEL HT PB
- K Number
- K990142
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Sulzer Oscor, Inc.
- Date Received
- January 19, 1999
- Decision Date
- July 30, 1999
- Product Code
- DTB
- 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 |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | FDA class 3 | Cardiovascular |
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Other Clearances by Sulzer Oscor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970497 | PACE 101H | Jun 4, 1997 | Substantially Equivalent |