CTC 30, 40, 1 LIQUID OXYGEN LITERS— 510(k) K860738

Name: FDA 510(k) clearance K860738
Creator: U.S. Food and Drug Administration
Published: 1986-08-06

Substantially Equivalent

Cryodyne Technologies, Inc.

FDA 510(k) clearance K860738 for CTC 30, 40, 1 LIQUID OXYGEN LITERS, Substantially Equivalent on 1986-08-06. Applicant: Cryodyne Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Cryodyne Technologies, Inc.
Product code: Code BYJ
Device class: Class 2
Regulation: 21 CFR 868.5655
Advisory panel: Anesthesiology
Date received: 1986-02-27
Decision date: 1986-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riviera Beach, FL, US

Download summary PDF View on FDA.gov ↗

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K926464 — L.C.S.30001993-08-24
K932520 — CALIBRATION GAS1993-08-19
K881465 — CRYOBIOLOGICAL FREEZER1988-04-21
K881466 — CELL-CULTURE SHAKER1988-04-18
K881467 — MICROSCOPE STAGE HEATER1988-04-18

Adverse events under product code BYJ

product code BYJ

Death: 16
Total: 16

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.