The following data is part of a premarket notification filed by Pro-tech, Inc. with the FDA for Freedom Oximeter/eeg Digital Interface.
Device ID | K924752 |
510k Number | K924752 |
Device Name: | FREEDOM OXIMETER/EEG DIGITAL INTERFACE |
Classification | Oximeter |
Applicant | PRO-TECH, INC. P.O. BOX 2165 17710-134TH AVENUE N.E. Woodinville, WA 98072 |
Contact | Randy Carruthers |
Correspondent | Randy Carruthers PRO-TECH, INC. P.O. BOX 2165 17710-134TH AVENUE N.E. Woodinville, WA 98072 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-23 |
Decision Date | 1993-09-10 |