The following data is part of a premarket notification filed by Siemens Medical Electronics with the FDA for Siemens Sao2 + Puls Oximetry Cartridge.
Device ID | K893470 |
510k Number | K893470 |
Device Name: | SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE |
Classification | Oximeter |
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 | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-04 |
Decision Date | 1989-08-03 |