The following data is part of a premarket notification filed by Lintronics Industries, Inc. with the FDA for Z View Meter Model 300.
Device ID | K830823 |
510k Number | K830823 |
Device Name: | Z VIEW METER MODEL 300 |
Classification | Tester, Electrode, Surface, Electrocardiographic |
Applicant | LINTRONICS INDUSTRIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KRC |
CFR Regulation Number | 870.2370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-15 |
Decision Date | 1983-05-18 |