Implantable Programmable Unipolar Card.
FDA 510(k) K800603 · Telectronics, Inc.
510(k) numberK800603
Submission
- Device name
- Implantable Programmable Unipolar Card.
- Applicant
- Telectronics, Inc.
Mchenry, IL, US - Received
- March 17, 1980
- Decision date
- March 25, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Telectronics, Inc.
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| K884411 | Optima MPT and SPT PacemakersDXY · Traditional | 01/26/1989SE |
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| K881837 | Optima MPT Series III Pacemaker, 5281D and 5282DDXY · Traditional | 07/18/1988SE |
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| K864712 | Model 1740 Personal Pocket ProgrammerKRG · Traditional | 12/17/1987SE |
| K872766 | Implantable Programmable Cardiac Pulse GeneratorsDXY · Traditional | 11/04/1987SE |
| K865098 | Slimline Unipolar Endocardial Pacing Lead, 030-438DTB · Traditional | 08/18/1987SE |
Questions and answers
When was Implantable Programmable Unipolar Card. cleared by the FDA?
Implantable Programmable Unipolar Card. (K800603) received a 510(k) decision of Substantially Equivalent on March 25, 1980, 8 days after the submission was received.