The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Miniaturized Finger Clip Pulse Oximeter.
| Device ID | K942248 |
| 510k Number | K942248 |
| Device Name: | MINIATURIZED FINGER CLIP PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 2605 FERNBROOK LANE, NORTH Minneapolis, MN 55447 -4755 |
| Contact | Philip Isaacson |
| Correspondent | Philip Isaacson 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 | 1994-05-09 |
| Decision Date | 1994-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00833166000085 | K942248 | 000 |