GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM— 510(k) K070210

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K070210 for GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM, Substantially Equivalent on 2007-04-20. Applicant: Ohmeda Medical.

Clearance details

Applicant: Ohmeda Medical
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 2007-01-22
Decision date: 2007-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laurel, MD, US

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.