The following data is part of a premarket notification filed by Palco Labs, Inc. with the FDA for Model 120.
| Device ID | K994372 |
| 510k Number | K994372 |
| Device Name: | MODEL 120 |
| Classification | Oximeter |
| Applicant | PALCO LABS, INC. 8030 SOQUEL AVE. Santa Cruz, CA 95062 |
| Contact | Richella Goo |
| Correspondent | Richella Goo PALCO LABS, INC. 8030 SOQUEL AVE. Santa Cruz, CA 95062 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-27 |
| Decision Date | 2000-04-28 |