The following data is part of a premarket notification filed by Leonides Y. Teves, M.d., P.a. with the FDA for Teves Ecm (endotracheal Cardiac Monitor).
| Device ID | K893609 |
| 510k Number | K893609 |
| Device Name: | TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR) |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | LEONIDES Y. TEVES, M.D., P.A. THE PALMS BUILDING 623-39TH STREET WEST Bradenton, FL 33505 |
| Contact | Leonides Y Teves |
| Correspondent | Leonides Y Teves LEONIDES Y. TEVES, M.D., P.A. THE PALMS BUILDING 623-39TH STREET WEST Bradenton, FL 33505 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-10 |
| Decision Date | 1989-10-30 |