ERA 2000 EMERGENCY RESUSCITATOR— 510(k) K884089

Substantially Equivalent

Neotronics Medical , Ltd.

FDA 510(k) clearance K884089 for ERA 2000 EMERGENCY RESUSCITATOR, Substantially Equivalent on 1988-12-20. Applicant: Neotronics Medical , Ltd..

Clearance details

Applicant: Neotronics Medical , Ltd.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 1988-09-28
Decision date: 1988-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bishop'S Stortford, GB

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Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.