The following data is part of a premarket notification filed by Nellcor, Inc. with the FDA for Nellcor N-200 (pulse Oximeter).
| Device ID | K863784 |
| 510k Number | K863784 |
| Device Name: | NELLCOR N-200 (PULSE OXIMETER) |
| Classification | Oximeter |
| Applicant | NELLCOR, INC. 25495 WHITESELL ST. Hayward, CA 94545 |
| Contact | Barbara J Black |
| Correspondent | Barbara J Black NELLCOR, INC. 25495 WHITESELL ST. Hayward, CA 94545 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-26 |
| Decision Date | 1986-11-21 |