The following data is part of a premarket notification filed by Micromedical, Inc. with the FDA for Printer Interface.
Device ID | K970305 |
510k Number | K970305 |
Device Name: | PRINTER INTERFACE |
Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
Applicant | MICROMEDICAL, INC. 255 REVERE DR., SUITE 111 Northbrook, IL 60062 |
Contact | Malcolm Castle |
Correspondent | Malcolm Castle MICROMEDICAL, INC. 255 REVERE DR., SUITE 111 Northbrook, IL 60062 |
Product Code | DXH |
CFR Regulation Number | 870.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-01-27 |
Decision Date | 1997-08-15 |
Summary: | summary |