The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Pulse Oximeter.
| Device ID | K855027 |
| 510k Number | K855027 |
| Device Name: | PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Contact | Gail E Nova |
| Correspondent | Gail E Nova PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-16 |
| Decision Date | 1986-05-16 |