The following data is part of a premarket notification filed by Advanced Medical Products, Inc. with the FDA for Model 192 Printer.
Device ID | K870538 |
510k Number | K870538 |
Device Name: | MODEL 192 PRINTER |
Classification | Recorder, Paper Chart |
Applicant | ADVANCED MEDICAL PRODUCTS, INC. FIVE ADLER DR. E. Syracuse, NY 13057 |
Contact | James H Brown |
Correspondent | James H Brown ADVANCED MEDICAL PRODUCTS, INC. FIVE ADLER DR. E. Syracuse, NY 13057 |
Product Code | DSF |
CFR Regulation Number | 870.2810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-09 |
Decision Date | 1987-04-23 |