The following data is part of a premarket notification filed by Medical Cables, Inc. with the FDA for Spo2 Finger Probes.
Device ID | K973970 |
510k Number | K973970 |
Device Name: | SPO2 FINGER PROBES |
Classification | Oximeter |
Applicant | MEDICAL CABLES, INC. 1340 LOGAN AVE. Costa Mesa, CA 92626 |
Contact | Christopher J Fontana |
Correspondent | Christopher J Fontana MEDICAL CABLES, INC. 1340 LOGAN AVE. Costa Mesa, CA 92626 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-17 |
Decision Date | 1998-10-06 |