The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Nellcor Symphony N-3000 Patient Monitor With Spo2 And Ecg And N-3200 Display/printer.
| Device ID | K963400 |
| 510k Number | K963400 |
| Device Name: | NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER |
| Classification | Electrocardiograph |
| Applicant | NELLCOR PURITAN BENNETT, INC. 11150 THOMPSON AVE. Lenexa, KS 66219 -2301 |
| Contact | David A Green |
| Correspondent | David A Green NELLCOR PURITAN BENNETT, INC. 11150 THOMPSON AVE. Lenexa, KS 66219 -2301 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-29 |
| Decision Date | 1996-11-26 |
| Summary: | summary |