FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
MODEL 5600B PROGRAMMER, PACEMAKER
K Number: K871986
·
Decision Jun 24, 1987
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
24
Applicant Total
107
Review Days
33
Basic Information
- Device Name
- MODEL 5600B PROGRAMMER, PACEMAKER
- K Number
- K871986
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- TELECTRONICS, INC.
- Date Received
- May 22, 1987
- Decision Date
- June 24, 1987
- Product Code
- KRG
- 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 |
|---|---|---|---|
| KRG | Programmer, Pacemaker | FDA class 3 | Cardiovascular |
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|---|---|---|---|
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| K881837 | OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D | Jul 18, 1988 | Substantially Equivalent |
| K874664 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 | May 31, 1988 | Substantially Equivalent |
| K864712 | MODEL 1740 PERSONAL POCKET PROGRAMMER | Dec 17, 1987 | Substantially Equivalent |
| K872766 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | Nov 4, 1987 | Substantially Equivalent |
| K865098 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 | Aug 18, 1987 | Substantially Equivalent |