The following data is part of a premarket notification filed by Siemens Medical Electronics with the FDA for Siemens Sirecust 732, Patient Monitor.
Device ID | K901771 |
510k Number | K901771 |
Device Name: | SIEMENS SIRECUST 732, PATIENT MONITOR |
Classification | Electrocardiograph |
Applicant | SIEMENS MEDICAL ELECTRONICS 16 ELECTRONICS AVE. Danvers, MA 01923 |
Contact | R Murfitt,phd |
Correspondent | R Murfitt,phd 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 | 1990-04-19 |
Decision Date | 1990-05-30 |