The following data is part of a premarket notification filed by Nellcor, Inc. with the FDA for Pulse Oximeter Model 100.
| Device ID | K822909 |
| 510k Number | K822909 |
| Device Name: | PULSE OXIMETER MODEL 100 |
| Classification | Oximeter |
| Applicant | NELLCOR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-30 |
| Decision Date | 1982-11-01 |