The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Patient Mon 1280/1281/120c/121c & Multi-para Cart.
Device ID | K860646 |
510k Number | K860646 |
Device Name: | PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART |
Classification | Electrocardiograph |
Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
Contact | Marvin Rosenbaum |
Correspondent | Marvin Rosenbaum ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-20 |
Decision Date | 1986-10-16 |