The following data is part of a premarket notification filed by Nellcor, Inc. with the FDA for Nellcor Symphony N-3100 Blood Pressure Monitor.
| Device ID | K953472 |
| 510k Number | K953472 |
| Device Name: | NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NELLCOR, INC. 4280 HACIENDA DR. P.O. BOX 8004 Pleasanton, CA 94588 |
| Contact | Marsha J Stone |
| Correspondent | Marsha J Stone NELLCOR, INC. 4280 HACIENDA DR. P.O. BOX 8004 Pleasanton, CA 94588 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-24 |
| Decision Date | 1995-10-20 |