The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Nonin Medical, Inc. Finger Phantom For Pulse Oximeters.
| Device ID | K940463 |
| 510k Number | K940463 |
| Device Name: | NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 2605 FERNBROOK LANE, NORTH Minneapolis, MN 55447 -4755 |
| Contact | Jerry Zweigbaum |
| Correspondent | Jerry Zweigbaum NONIN MEDICAL, INC. 2605 FERNBROOK LANE, NORTH Minneapolis, MN 55447 -4755 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-02 |
| Decision Date | 1994-03-14 |