The following data is part of a premarket notification filed by Colorado Medtech, Inc. with the FDA for First Medic Pulse Oximetry Module.
Device ID | K955890 |
510k Number | K955890 |
Device Name: | FIRST MEDIC PULSE OXIMETRY MODULE |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | COLORADO MEDTECH, INC. 6175 LONGBOW DR. Boulder, CO 80301 |
Contact | Bonnie J Norman |
Correspondent | Bonnie J Norman COLORADO MEDTECH, INC. 6175 LONGBOW DR. Boulder, CO 80301 |
Product Code | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-29 |
Decision Date | 1997-07-28 |