The following data is part of a premarket notification filed by Zmi Corp. with the FDA for Noninvasive Temp. Pacemaker Ntp-1000.
| Device ID | K855015 |
| 510k Number | K855015 |
| Device Name: | NONINVASIVE TEMP. PACEMAKER NTP-1000 |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | ZMI CORP. 325 VASSAR ST. Cambridge, MA 02139 |
| Contact | Rolf S Stutz |
| Correspondent | Rolf S Stutz ZMI CORP. 325 VASSAR ST. Cambridge, MA 02139 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-16 |
| Decision Date | 1986-03-31 |