The following data is part of a premarket notification filed by Zmi Corp. with the FDA for Pediatric Multi-function Electrodes.
| Device ID | K915159 |
| 510k Number | K915159 |
| Device Name: | PEDIATRIC MULTI-FUNCTION ELECTRODES |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | ZMI CORP. 500 WEST CUMMINGS PARK Woburn, MA 01801 |
| Contact | Rod Boucher |
| Correspondent | Rod Boucher ZMI CORP. 500 WEST CUMMINGS PARK Woburn, MA 01801 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-14 |
| Decision Date | 1992-02-07 |