The following data is part of a premarket notification filed by Siemens Medical Electronics with the FDA for Siemens Sirecust 700 Bedsides/accessories, Modifi.
Device ID | K921930 |
510k Number | K921930 |
Device Name: | SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFI |
Classification | Electrocardiograph |
Applicant | SIEMENS MEDICAL ELECTRONICS 16 ELECTRONICS AVE. Danvers, MA 01923 |
Contact | Robert R Murfitt |
Correspondent | Robert R Murfitt SIEMENS MEDICAL ELECTRONICS 16 ELECTRONICS AVE. Danvers, MA 01923 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-24 |
Decision Date | 1993-05-07 |