Telectronics Model 2401
FDA 510(k) K831697 · Seamed Corp.
510(k) numberK831697
Submission
- Device name
- Telectronics Model 2401
- Applicant
- Seamed Corp.
Walker, MI, US - Received
- May 25, 1983
- Decision date
- September 4, 1984
- 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 |
|---|---|---|
| K923398 | Cpi Model 2215DTE · Traditional | 08/14/1992SE |
| K915364 | Chronocor Vi Model 5012DTE · Traditional | 02/07/1992SE |
| K912507 | Cpi Model 2215 & Seamed Model 3400DTE · Traditional | 09/03/1991SE |
| K910223 | Cpi Model 2215/SEAMED Model 3400DTC · Traditional | 03/19/1991SE |
| K883930 | Seamed Model 3300 Dual Chamber Pacing System AnalyDTE · Traditional | 11/09/1988SE |
| K872551 | Seamed Model 3200DTE · Traditional | 07/31/1987SE |
| K863903 | Sea Med Model 6000DTE · Traditional | 12/10/1986SE |
| K860462 | Seamed Model 3000DTC · Traditional | 08/19/1986SE |
| K854648 | Seamed Model 4000DTE · Traditional | 01/16/1986SE |
| K852746 | External Pacemaker Telectronics TE200JOQ · Traditional | 09/12/1985SE |
Questions and answers
When was Telectronics Model 2401 cleared by the FDA?
Telectronics Model 2401 (K831697) received a 510(k) decision of Substantially Equivalent on September 4, 1984, 468 days after the submission was received.
What is the product code of K831697?
The FDA product code is DTC – Analyzer, Pacemaker Generator Function, a Class II (moderate risk) device regulated under 21 CFR 870.3630.