LIBERATOR/STROLLER II SYSTEM— 510(k) K800742
Substantially EquivalentCryogenic Assoc.
FDA 510(k) clearance K800742 for LIBERATOR/STROLLER II SYSTEM, Substantially Equivalent on 1980-05-23. Applicant: Cryogenic Assoc.. Device class: 2.
Clearance details
- Applicant
- Cryogenic Assoc.
- Product code
- Code BYJ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5655
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code BYJ
view allMore clearances from Cryogenic Assoc.
view allAdverse events under product code BYJ
product code BYJ- Death
- 16
- Total
- 16
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K800742
K-number listed on FDA's recall record- Z-0336-2023 — CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
- Z-0337-2023 — CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
- Z-0338-2023 — CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
- Z-0339-2023 — CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K800742.
Data sourced from openFDA. This site is unofficial and independent of the FDA.