The following data is part of a premarket notification filed by Phoenix Medical Technology, Inc. with the FDA for Dobe (modified).
| Device ID | K853993 |
| 510k Number | K853993 |
| Device Name: | DOBE (MODIFIED) |
| Classification | Electrode, Electrocardiograph |
| Applicant | PHOENIX MEDICAL TECHNOLOGY, INC. HWY. 521 WEST, P.O. BOX 346 Andrews, SC 29510 |
| Contact | Sauve |
| Correspondent | Sauve PHOENIX MEDICAL TECHNOLOGY, INC. HWY. 521 WEST, P.O. BOX 346 Andrews, SC 29510 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-27 |
| Decision Date | 1986-02-28 |