Electrode/Pacer System Analyzer Pma 400
FDA 510(k) K810604 · Telectronics, Inc.
510(k) numberK810604
Submission
- Device name
- Electrode/Pacer System Analyzer Pma 400
- Applicant
- Telectronics, Inc.
Mchenry, IL, US - Received
- March 6, 1981
- Decision date
- April 14, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTC – Analyzer, Pacemaker Generator Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3630
- Specialty
- Cardiovascular
Other 510(k)s with product code DTC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170815 | PSA CableDTC · Traditional | Boston Scientific Corporation | 07/06/2017SE |
| K083674 | PK-141 Patient CableDTC · Traditional | Biotronik, Inc. | 04/01/2009SE |
| K011729 | Sigma Pace External Pacemaker Analyzer Model #1000DTC · Traditional | Dni Nevada, Inc. | 08/30/2001SE |
| K002497 | Model 4810 Analyzer Output AdapterDTC · Traditional | Pace Medical | 10/10/2000SE |
| K961582 | External Pacemaker Analyzer, Model PMT 100DTC · Traditional | North American Technical Services Corp. | 11/08/1996SE |
| K903966 | External Pacemaker Analyzer Model PMA-1DTC · Traditional | Bio-Tek Instruments, Inc. | 06/19/1991SE |
| K910595 | Model 5311B A-V Pacing System AnalyzerDTC · Traditional | Medtronic Vascular | 05/07/1991SE |
| K910223 | Cpi Model 2215/SEAMED Model 3400DTC · Traditional | Seamed Corp. | 03/19/1991SE |
| K901332 | PK-55 Andover Medical Part #5455 Label ChangeDTC · Traditional | Biotronik, GmbH & Co. | 05/09/1990SE |
| K896632 | Medtronic Model 5401B Test CableDTC · Traditional | Medtronic Vascular | 12/13/1989SE |
More from Medtronic Vascular
| 510(k) | Device | Decision |
|---|---|---|
| K890895 | Implantable Adaptor 033-380DTD · Traditional | 03/06/1990SE |
| K891231 | Optima MPT and SPT PacemakersDXY · Traditional | 09/12/1989SE |
| K890350 | VS-1 Silicone Implant Leads (New Serial # Tube)DTB · Traditional | 02/02/1989SE |
| K884411 | Optima MPT and SPT PacemakersDXY · Traditional | 01/26/1989SE |
| K884278 | Implantable Electrode Leads 033-400,402 and 436DTB · Traditional | 12/15/1988SE |
| K881837 | Optima MPT Series III Pacemaker, 5281D and 5282DDXY · Traditional | 07/18/1988SE |
| K874664 | Implantable Electrode Lead, Model 030-446DTB · Traditional | 05/31/1988SE |
| 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 Electrode/Pacer System Analyzer Pma 400 cleared by the FDA?
Electrode/Pacer System Analyzer Pma 400 (K810604) received a 510(k) decision of Substantially Equivalent on April 14, 1981, 39 days after the submission was received.
What is the product code of K810604?
The FDA product code is DTC – Analyzer, Pacemaker Generator Function, a Class II (moderate risk) device regulated under 21 CFR 870.3630.