The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Mingograf 4, Mingo Card 4 & Minocard 3.
Device ID | K822978 |
510k Number | K822978 |
Device Name: | MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3 |
Classification | Recorder, Paper Chart |
Applicant | SIEMENS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DSF |
CFR Regulation Number | 870.2810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-08 |
Decision Date | 1982-12-15 |