The following data is part of a premarket notification filed by Technomed Europe with the FDA for Laryngeal Electrode.
Device ID | K121257 |
510k Number | K121257 |
Device Name: | LARYNGEAL ELECTRODE |
Classification | Stimulator, Nerve |
Applicant | TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
Contact | Pierre Vreuls |
Correspondent | Pierre Vreuls TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
Product Code | ETN |
CFR Regulation Number | 874.1820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-26 |
Decision Date | 2012-08-28 |
Summary: | summary |