Submission Details
| 510(k) Number | K990648 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 01, 1999 |
| Decision Date | August 10, 1999 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
K990648 is an FDA 510(k) clearance for the KELLER VITAL SIGNS MONITOR, KMS 890+, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Keller Medical Specialties Products, Inc. (Antioch, US). The FDA issued a Cleared decision on August 10, 1999, 162 days after receiving the submission on March 1, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K990648 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 01, 1999 |
| Decision Date | August 10, 1999 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXN — System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1130 |