The following data is part of a premarket notification filed by Inomed Medizintechnik Gmbh with the FDA for Inomed Adhesive Laryngeal Electrodes, Models 530655, 530656.
| Device ID | K091874 |
| 510k Number | K091874 |
| Device Name: | INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 |
| Classification | Stimulator, Nerve |
| Applicant | INOMED MEDIZINTECHNIK GMBH 1468 HARWELL AVE Crofton, MD 21114 |
| Contact | Yolanda Smith |
| Correspondent | Yolanda Smith INOMED MEDIZINTECHNIK GMBH 1468 HARWELL AVE Crofton, MD 21114 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-23 |
| Decision Date | 2009-11-18 |
| Summary: | summary |