The following data is part of a premarket notification filed by Physiometrix, Inc. with the FDA for Physiometrix Cable Adapter Modification.
Device ID | K935260 |
510k Number | K935260 |
Device Name: | PHYSIOMETRIX CABLE ADAPTER MODIFICATION |
Classification | Cable, Electrode |
Applicant | PHYSIOMETRIX, INC. 575 N. PASTORIA AVE. Sunnyvale, CA 94086 |
Contact | Claire Andrews |
Correspondent | Claire Andrews PHYSIOMETRIX, INC. 575 N. PASTORIA AVE. Sunnyvale, CA 94086 |
Product Code | IKD |
CFR Regulation Number | 890.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-02 |
Decision Date | 1993-12-23 |