The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Dma Oxygen Monitor.
Device ID | K852823 |
510k Number | K852823 |
Device Name: | DMA OXYGEN MONITOR |
Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
Applicant | FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
Product Code | CCL |
CFR Regulation Number | 868.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-01 |
Decision Date | 1985-10-29 |