FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPID ATRIAL PACER
K Number: K831381
·
Decision Aug 31, 1983
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
64
Applicant Total
18
Review Days
125
Basic Information
- Device Name
- RAPID ATRIAL PACER
- K Number
- K831381
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- SEAMED CORP.
- Date Received
- April 28, 1983
- Decision Date
- August 31, 1983
- 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 |
| K863903 | SEA MED MODEL 6000 | Dec 10, 1986 | 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 |