The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Mini-pecg.
Device ID | K832883 |
510k Number | K832883 |
Device Name: | MINI-PECG |
Classification | Electrocardiograph |
Applicant | INTERSECT SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-26 |
Decision Date | 1983-12-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MINI-PECG 73443331 1298671 Dead/Cancelled |
Intech Systems Corp. 1983-09-12 |