The following data is part of a premarket notification filed by Keller Medical Specialties Products, Inc. with the FDA for Keller Pulse Oximeter, Model 850+.
| Device ID | K982331 |
| 510k Number | K982331 |
| Device Name: | KELLER PULSE OXIMETER, MODEL 850+ |
| Classification | Oximeter |
| Applicant | KELLER MEDICAL SPECIALTIES PRODUCTS, INC. 42609 CRAWFORD RD. Antioch, IL 60002 |
| Contact | Jean Keller |
| Correspondent | Jean Keller KELLER MEDICAL SPECIALTIES PRODUCTS, INC. 42609 CRAWFORD RD. Antioch, IL 60002 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-02 |
| Decision Date | 1998-09-11 |
| Summary: | summary |