The following data is part of a premarket notification filed by Palco Laboratories, Inc. with the FDA for Palco Labs Model 300 Oxygen/pulse Monitor.
| Device ID | K911191 |
| 510k Number | K911191 |
| Device Name: | PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR |
| Classification | Oximeter |
| Applicant | PALCO LABORATORIES, INC. 8030 SOQUEL AVE. Santa Cruz, CA 95062 |
| Contact | Paul D Levin |
| Correspondent | Paul D Levin PALCO LABORATORIES, 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 | 1991-03-18 |
| Decision Date | 1991-06-10 |