RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR— 510(k) K892885

Substantially Equivalent

Fisher & Paykel Electronics , Ltd.

FDA 510(k) clearance K892885 for RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR, Substantially Equivalent on 1989-10-06. Applicant: Fisher & Paykel Electronics , Ltd..

Clearance details

Applicant: Fisher & Paykel Electronics , Ltd.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 1989-04-19
Decision date: 1989-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, New Zealand, NZ

Download summary PDF View on FDA.gov ↗

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.