ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
FDA 510(k) clearance K982104 · decided 1998-11-25
Clearance details
- K-number
- K982104
- Device name
- ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
- Applicant
- Medical Data Electronics
- Decision
- Substantially Equivalent
- Date received
- 1998-06-15
- Decision date
- 1998-11-25
- Days to decision
- 163 days
- Clearance type
- Special
- Product code
- MLD
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Arleta, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medical Data Electronics
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.