PULSAIR I & II— 510(k) K833994

Name: FDA 510(k) clearance K833994
Creator: U.S. Food and Drug Administration
Published: 1983-12-12

Substantially Equivalent

Cryo Corp.

FDA 510(k) clearance K833994 for PULSAIR I & II, Substantially Equivalent on 1983-12-12. Applicant: Cryo Corp.. Device class: 2.

Clearance details

Applicant: Cryo Corp.
Product code: Code BYJ
Device class: Class 2
Regulation: 21 CFR 868.5655
Advisory panel: Anesthesiology
Date received: 1983-11-21
Decision date: 1983-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K872145 — CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)1987-11-13
K834569 — VENTILATORY FREQUENCY MONITOR1984-03-30

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.