CLASSIC ECG/STIMULATING NO. 1700 SERIES— 510(k) K900519

Substantially Equivalent

Classic Medical Products, Inc.

FDA 510(k) clearance K900519 for CLASSIC ECG/STIMULATING NO. 1700 SERIES, Substantially Equivalent on 1990-03-19. Applicant: Classic Medical Products, Inc..

Clearance details

Applicant: Classic Medical Products, Inc.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1990-02-02
Decision date: 1990-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Muskego, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.