The following data is part of a premarket notification filed by Physiometrix, Inc. with the FDA for Trigel Multifunction Electrode.
| Device ID | K934505 |
| 510k Number | K934505 |
| Device Name: | TRIGEL MULTIFUNCTION ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| 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 | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-15 |
| Decision Date | 1994-11-22 |