Submission Details
| 510(k) Number | K982104 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 15, 1998 |
| Decision Date | November 25, 1998 |
| Days to Decision | 163 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
Nov 1998
Decision
163d
Days
Class 2
Risk
About This 510(k) Submission
K982104 is an FDA 510(k) clearance for the ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500, a Monitor, St Segment With Alarm (Class II — Special Controls, product code MLD), submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on November 25, 1998, 163 days after receiving the submission on June 15, 1998. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.
Device Classification
| Product Code | MLD — Monitor, St Segment With Alarm |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1025 |
Manufacturer
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