The following data is part of a premarket notification filed by Nellcor, Inc. with the FDA for Nellcor Symphony(tm) N-3100 Blood Pressure Monitor And Connected To The Nellcor Symphony(tm) N-3000 Pulse Oximeter.
| Device ID | K945947 |
| 510k Number | K945947 |
| Device Name: | NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NELLCOR, INC. 11150 THOMPSON AVE. Lenexa, KS 66219 |
| Contact | David Green |
| Correspondent | David Green NELLCOR, INC. 11150 THOMPSON AVE. Lenexa, KS 66219 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-06 |
| Decision Date | 1995-03-08 |