The following data is part of a premarket notification filed by Mecta Corp. with the FDA for Mecta Ect Device Models Sr & Jr.
Device ID | K852069 |
510k Number | K852069 |
Device Name: | MECTA ECT DEVICE MODELS SR & JR |
Classification | Device, Electroconvulsive Therapy |
Applicant | MECTA CORP. 122 SOUTHEAST AVE. 8TH. AVENUE #A Portland, OR 97214 |
Contact | Rex Hiatt |
Correspondent | Rex Hiatt MECTA CORP. 122 SOUTHEAST AVE. 8TH. AVENUE #A Portland, OR 97214 |
Product Code | GXC |
CFR Regulation Number | 882.5940 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-10 |
Decision Date | 1985-08-09 |