FDA 510(k)
Substantially Equivalent
🇺🇸 United States
IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD.
K Number: K800603
·
Decision Mar 25, 1980
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
107
Review Days
8
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Basic Information
- Device Name
- IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD.
- K Number
- K800603
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Telectronics, Inc.
- Date Received
- March 17, 1980
- Decision Date
- March 25, 1980
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Other Clearances by Telectronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K890895 | IMPLANTABLE ADAPTOR 033-380 | Mar 6, 1990 | Substantially Equivalent |
| K891231 | OPTIMA MPT AND SPT PACEMAKERS | Sep 12, 1989 | Substantially Equivalent |
| K890350 | VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) | Feb 2, 1989 | Substantially Equivalent |
| K884411 | OPTIMA MPT AND SPT PACEMAKERS | Jan 26, 1989 | Substantially Equivalent |
| K884278 | IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 | Dec 15, 1988 | Substantially Equivalent |
| 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 |