The following data is part of a premarket notification filed by Zmi Corp. with the FDA for Zoll Ntp-1200 Pacer/defibrillator.
Device ID | K873402 |
510k Number | K873402 |
Device Name: | ZOLL NTP-1200 PACER/DEFIBRILLATOR |
Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
Applicant | ZMI CORP. 325 VASSAR ST. Cambridge, MA 02139 |
Contact | Paul A Levesque |
Correspondent | Paul A Levesque 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 | 1987-08-24 |
Decision Date | 1987-11-23 |