The following data is part of a premarket notification filed by Cortronic Corp. with the FDA for Cortronic Apm 770 Noninvasive & Arterial Press Mon.
Device ID | K852547 |
510k Number | K852547 |
Device Name: | CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | CORTRONIC CORP. 260 MAIN ST. Northport, NY 11768 |
Contact | Ted W Russell |
Correspondent | Ted W Russell CORTRONIC CORP. 260 MAIN ST. Northport, NY 11768 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-14 |
Decision Date | 1986-11-10 |