The following data is part of a premarket notification filed by Edwards Pacemaker Systems with the FDA for Analyzer, Pacer System, Psa-5.
Device ID | K781144 |
510k Number | K781144 |
Device Name: | ANALYZER, PACER SYSTEM, PSA-5 |
Classification | Analyzer, Pacemaker Generator Function |
Applicant | EDWARDS PACEMAKER SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTC |
CFR Regulation Number | 870.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-07-10 |
Decision Date | 1978-08-23 |