FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEA MED MODEL 6000
K Number: K863903
·
Decision Dec 10, 1986
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
18
Review Days
64
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Basic Information
- Device Name
- SEA MED MODEL 6000
- K Number
- K863903
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Seamed Corp.
- Date Received
- October 7, 1986
- Decision Date
- December 10, 1986
- 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 Seamed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K923398 | CPI MODEL 2215 | Aug 14, 1992 | Substantially Equivalent |
| K915364 | CHRONOCOR VI MODEL 5012 | Feb 7, 1992 | Substantially Equivalent |
| K912507 | CPI MODEL 2215 & SEAMED MODEL 3400 | Sep 3, 1991 | Substantially Equivalent |
| K910223 | CPI MODEL 2215/SEAMED MODEL 3400 | Mar 19, 1991 | Substantially Equivalent |
| K883930 | SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY | Nov 9, 1988 | Substantially Equivalent |
| K872551 | SEAMED MODEL 3200 | Jul 31, 1987 | Substantially Equivalent |
| K860462 | SEAMED MODEL 3000 | Aug 19, 1986 | Substantially Equivalent |
| K854648 | SEAMED MODEL 4000 | Jan 16, 1986 | Substantially Equivalent |
| K852746 | EXTERNAL PACEMAKER TELECTRONICS TE200 | Sep 12, 1985 | Substantially Equivalent |
| K851900 | SEA MED DDD PACING SYSTEM ANALYZER | Jul 19, 1985 | Substantially Equivalent |