The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Nonin Model 2120 Pulse Oximeter And Noninvasive Blood Pressure (nibp) Monitor.
| Device ID | K013319 |
| 510k Number | K013319 |
| Device Name: | NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 2605 FERNBROOK LANE, NORTH Minneapolis, MN 55447 -4755 |
| Contact | Richard P Bennett |
| Correspondent | Richard P Bennett 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 | 2001-10-05 |
| Decision Date | 2002-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849686073645 | K013319 | 000 |