510(k) K092364
- Device
- MODEL 220 PATIENT MAGNET
- Applicant
- CYBERONICS, INC.
- 510(k) number
- K092364
- Product code
- DTG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-11-03
- Date received
- 2009-08-05
- Regulation
- 870.3690
- Classification name
- Magnet, Test, Pacemaker
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN STUEBER
- Address
- 100 Cyberonics Blvd. Houston TX US 77058 77058
FDA Registration Numbers#
- 1000165971
- 2017865
- 3008159616
- 9610139
- 2182208
- 1644487
Source Documents#
Other 510(k) Records For Product Code DTG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960849 | MAGNO ALARM | Cardiac Assist Devices, Inc. | 1997-03-26 |
| K895110 | MAESTRO PACEMAKER TEST MAGNET | Cardiac Control Systems, Inc. | 1989-09-26 |
| K831926 | IMPLANTABLE ENDOCARDIAL PACING LEADS | Oscor, Inc. | 1984-03-12 |
| K813153 | TEST MAGNET | Pacesetter Systems | 1981-12-02 |
Legacy Summary#
summary
FDA Review#
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