The following data is part of a premarket notification filed by Keller Medical Specialties Products, Inc. with the FDA for Keller Vital Signs Monitor, Kms 890+.
| Device ID | K990648 |
| 510k Number | K990648 |
| Device Name: | KELLER VITAL SIGNS MONITOR, KMS 890+ |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | KELLER MEDICAL SPECIALTIES PRODUCTS, INC. 42609 CRAWFORD RD. Antioch, IL 60002 |
| Contact | Jean Wagner |
| Correspondent | Jean Wagner KELLER MEDICAL SPECIALTIES PRODUCTS, INC. 42609 CRAWFORD RD. Antioch, IL 60002 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-01 |
| Decision Date | 1999-08-10 |
| Summary: | summary |