The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Pulse-ox.
| Device ID | K863857 |
| 510k Number | K863857 |
| Device Name: | PULSE-OX |
| Classification | Oximeter |
| Applicant | LIFE DESIGN SYSTEMS, INC. 2735 EAST BELT LINE RD. Carrollton, TX 75006 |
| Contact | Gilbert M Kirk |
| Correspondent | Gilbert M Kirk LIFE DESIGN SYSTEMS, INC. 2735 EAST BELT LINE RD. Carrollton, TX 75006 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-02 |
| Decision Date | 1987-10-07 |