The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Myocardial Probe Thermometer Code 64000.
| Device ID | K893418 |
| 510k Number | K893418 |
| Device Name: | MYOCARDIAL PROBE THERMOMETER CODE 64000 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Robert E Jankun |
| Correspondent | Robert E Jankun DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-02 |
| Decision Date | 1989-09-05 |