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 |