Pacing System Analyzer Psa SCE-22
FDA 510(k) K791975 · Ela Medical, Inc.
510(k) numberK791975
Submission
- Device name
- Pacing System Analyzer Psa SCE-22
- Applicant
- Ela Medical, Inc.
Mchenry, IL, US - Received
- October 2, 1979
- Decision date
- January 31, 1980
- 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 |
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| 510(k) | Device | Decision |
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| K042002 | Synescope, Easyscope, Synecom, HolterreaderDQK · Traditional | 10/20/2004SE |
| K032466 | SpiderviewMWJ · Special | 08/22/2003SE |
| K002817 | SynetecDQK · Traditional | 05/02/2001SE |
| K993448 | Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped…DTB · Traditional | 04/10/2000ST |
| K000029 | Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped…DTB · Traditional | 04/04/2000SE |
| K990727 | Syneflash & SyneviewDQK · Traditional | 11/26/1999SE |
| K972574 | Stela Model UJ45 Pacing LeadsDTB · Traditional | 01/08/1998ST |
| K970072 | Opus S Model 4121 and 4124 PacemakersDXY · Traditional | 08/29/1997ST |
| K963738 | Stela Model BJ44 and BJ45 Pacing LeadsDTB · Traditional | 05/23/1997PT |
| K952364 | Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)DXY · Traditional | 09/01/1995ST |
Questions and answers
When was Pacing System Analyzer Psa SCE-22 cleared by the FDA?
Pacing System Analyzer Psa SCE-22 (K791975) received a 510(k) decision of Substantially Equivalent on January 31, 1980, 121 days after the submission was received.
What is the product code of K791975?
The FDA product code is DTC – Analyzer, Pacemaker Generator Function, a Class II (moderate risk) device regulated under 21 CFR 870.3630.