Test Magnet
FDA 510(k) K813153 · Pacesetter Systems
510(k) numberK813153
Submission
- Device name
- Test Magnet
- Applicant
- Pacesetter Systems
Walker, MI, US - Received
- November 6, 1981
- Decision date
- December 2, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTG – Magnet, Test, Pacemaker
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.3690
- Specialty
- Cardiovascular
Other 510(k)s with product code DTG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092364 | Model 220 Patient MagnetDTG · Traditional | Cyberonics, Inc. | 11/03/2009SE |
| K960849 | Magno AlarmDTG · Traditional | Cardiac Assist Devices, Inc. | 03/26/1997SE |
| K895110 | Maestro Pacemaker Test MagnetDTG · Traditional | Cardiac Control Systems, Inc. | 09/26/1989SE |
| K831926 | Implantable Endocardial Pacing LeadsDTG · Traditional | Oscor, Inc. | 03/12/1984SE |
More from Oscor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K910924 | Endocardial Leads-Mod. to the PolyvinylpyrrolidoneDTB · Traditional | 08/28/1991SE |
| K902147 | Endocardial Screw-In Lead Model 1028TDTB · Traditional | 07/17/1990SE |
| K900512 | Siemens Elema Models 4020T and 4021T AdaptersDTD · Traditional | 06/25/1990SE |
| K900550 | Fast-Pass Ace Models 1212T/1222T/1216T/1226TDTB · Traditional | 04/20/1990SE |
| K895447 | Endocardial Screw-In Lead Model 1020TDTB · Traditional | 12/20/1989SE |
| K891905 | Cardiovascular Permanent Pacemaker ElectrodeDTB · Traditional | 06/05/1989SE |
| K885267 | VS-1 Model Number 251K Pulse GeneratorDXY · Traditional | 03/28/1989SE |
| K890547 | Siemens Elema Models 4025 and 4026 AdaptersDTB · Traditional | 03/22/1989SE |
| K884733 | Afp Model 262T Pulse GeneratorDXY · Traditional | 02/10/1989SE |
| K883087 | Prolog MP 658M Pulse GeneratorDXY · Traditional | 09/14/1988SE |
Questions and answers
When was Test Magnet cleared by the FDA?
Test Magnet (K813153) received a 510(k) decision of Substantially Equivalent on December 2, 1981, 26 days after the submission was received.
What is the product code of K813153?
The FDA product code is DTG – Magnet, Test, Pacemaker, a Class I (low risk) device regulated under 21 CFR 870.3690.