The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Temp. Stylet Pacing Parobe 1318694.
| Device ID | K851845 |
| 510k Number | K851845 |
| Device Name: | NUMED TEMP. STYLET PACING PAROBE 1318694 |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
| Contact | Allen J Tower |
| Correspondent | Allen J Tower NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-26 |
| Decision Date | 1985-08-29 |