ELATEC HOLTER ANALYZER— 510(k) K895806
Substantially EquivalentEla Medical, Inc.
FDA 510(k) clearance K895806 for ELATEC HOLTER ANALYZER, Substantially Equivalent on 1990-04-04. Applicant: Ela Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Ela Medical, Inc.
- Product code
- Code DSI
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnetonka, MN, US
Recent devices under product code DSI
view allMore clearances from Ela Medical, Inc.
view all- K042002 — SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER
- K032466 — SPIDERVIEW
- K002817 — SYNETEC
- K993448 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
- K000029 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
Adverse events under product code DSI
product code DSI- Death
- 170
- Injury
- 729
- Malfunction
- 10,680
- Total
- 11,579
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.