CASSETTE READER— 510(k) K811253

Name: FDA 510(k) clearance K811253
Creator: U.S. Food and Drug Administration
Published: 1981-07-10

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K811253 for CASSETTE READER, Substantially Equivalent on 1981-07-10. Applicant: American Edwards Laboratories. Device class: 2.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 1981-05-05
Decision date: 1981-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSH

view all

K260157 — LifeLens Physiological Monitor2026-07-09
K252389 — Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)2026-04-23
K253293 — VitaloJAK Clinic (Model 7100)2025-12-03
K243650 — Zio® monitor (DFG0001)2025-08-15
K243603 — AeviceMD2025-05-05

More clearances from American Edwards Laboratories

view all

K873485 — EDSLAB (R) OCCLUSION BALLOON CATHETER1987-12-03
K872596 — TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F301987-09-30
K872529 — THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-21987-09-15
K870444 — HOMEPRO II VOLUMETRIC INFUSION PUMP1987-04-17
K864997 — MEDTRAC VP VOLUMETRIC INFUSION PUMP1987-02-27

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.