The following data is part of a premarket notification filed by Physiometrix, Inc. with the FDA for Drigel Defibrillator/synchronized Coardioversion.
| Device ID | K921207 |
| 510k Number | K921207 |
| Device Name: | DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION |
| Classification | Electrode, Electrocardiograph |
| Applicant | PHYSIOMETRIX, INC. 575 N. PASTORIA AVE. Sunnyvale, CA 94086 |
| Contact | Carole Sykes |
| Correspondent | Carole Sykes 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 | 1992-03-12 |
| Decision Date | 1992-10-13 |