FDA 510(k)
Substantially Equivalent
🇺🇸 United States
LEAD CONVERSION KIT, MODEL 341
K Number: K781111
·
Decision Aug 31, 1978
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
13
Review Days
59
Basic Information
- Device Name
- LEAD CONVERSION KIT, MODEL 341
- K Number
- K781111
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- EDWARDS PACEMAKER SYSTEMS
- Date Received
- July 3, 1978
- Decision Date
- August 31, 1978
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Other Clearances by EDWARDS PACEMAKER SYSTEMS
| K Number | Device Name | ||
|---|---|---|---|
| K791751 | EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR | Sep 26, 1979 | Substantially Equivalent |
| K790452 | 28 UNIPOLAR AND BIPOLAR PULSE GENERATORS | May 8, 1979 | Substantially Equivalent |
| K781144 | ANALYZER, PACER SYSTEM, PSA-5 | Aug 23, 1978 | Substantially Equivalent |
| K781042 | PROLITH 23S PACEMAKER | Jul 27, 1978 | Substantially Equivalent |
| K780780 | MICROPULSE 22S PACEMAKER | Jun 30, 1978 | Substantially Equivalent |
| K780238 | PACEMAKER, PROLITH 23U. PULSE GENERATOR | Mar 15, 1978 | Substantially Equivalent |
| K780091 | MICROPULSE 22U | Jan 30, 1978 | Substantially Equivalent |
| K771987 | MICROPULSE 26U PULSE GENERATOR | Nov 2, 1977 | Substantially Equivalent |
| K770656 | GENERATOR, PULSE, CARDIAC 20U | Apr 26, 1977 | Substantially Equivalent |
| K770657 | GENERATOR, PULSE, CARDIAC 2LU | Apr 26, 1977 | Substantially Equivalent |