The following data is part of a premarket notification filed by Zmi Corp. with the FDA for Zmi Part No. Ntp-2100, Pediatric Electrodes.
| Device ID | K885166 |
| 510k Number | K885166 |
| Device Name: | ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | ZMI CORP. 500 WEST CUMMINGS PARK Woburn, MA 01801 |
| Contact | Paul A Levesque |
| Correspondent | Paul A Levesque ZMI CORP. 500 WEST CUMMINGS PARK Woburn, MA 01801 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-13 |
| Decision Date | 1989-05-01 |