Model 674 Pacer Analyzer
FDA 510(k) K792074 · Del Mar Avionics
510(k) numberK792074
Submission
- Device name
- Model 674 Pacer Analyzer
- Applicant
- Del Mar Avionics
Mchenry, IL, US - Received
- October 15, 1979
- Decision date
- December 27, 1979
- 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 |
|---|---|---|
| K990027 | Omnicorder, Model 464DSH · Abbreviated | 02/09/1999SE |
| K971696 | Sentinel Recorder, Models 471/472DXH · Traditional | 12/30/1997SE |
| K963174 | Holter Digicorder with Pacer Option (Model 483)DSH · Traditional | 03/13/1997SE |
| K950020 | Holter Pacercorder(R)DSH · Traditional | 08/17/1995SE |
| K942653 | Holter SSR Digicorder(Tm)DSH · Traditional | 05/10/1995SE |
| K922221 | Sprint DX, Model 5400 Exercise Stress Test SystemLOS · Traditional | 04/21/1993SE |
| K896862 | Model 263 Spectrascan(Tm) Holter Analysis SystemDSI · Traditional | 04/18/1990SE |
| K895793 | Micropotential Analyzer/Spectrocardiography OptionDSH · Traditional | 02/13/1990SE |
| K894543 | Model 493 SSR-3 Three Channel Solid-State RecorderDSI · Traditional | 02/08/1990SE |
| K891148 | Model 152 Delta Holter ECG Analysis SystemDSI · Traditional | 05/11/1989SE |
Questions and answers
When was Model 674 Pacer Analyzer cleared by the FDA?
Model 674 Pacer Analyzer (K792074) received a 510(k) decision of Substantially Equivalent on December 27, 1979, 73 days after the submission was received.
What is the product code of K792074?
The FDA product code is DTC – Analyzer, Pacemaker Generator Function, a Class II (moderate risk) device regulated under 21 CFR 870.3630.