TIMETER-PRODUCED PURITAN BENNETT AIR ADP— 510(k) K812183

Name: FDA 510(k) clearance K812183
Creator: U.S. Food and Drug Administration
Published: 1981-08-18

Substantially Equivalent

Timeter Instrument Corp.

FDA 510(k) clearance K812183 for TIMETER-PRODUCED PURITAN BENNETT AIR ADP, Substantially Equivalent on 1981-08-18. Applicant: Timeter Instrument Corp.. Device class: 1.

Clearance details

Applicant: Timeter Instrument Corp.
Product code: Code CAX
Device class: Class 1
Regulation: 21 CFR 868.2340
Advisory panel: Anesthesiology
Date received: 1981-08-03
Decision date: 1981-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAX

product code CAX

Death: 3
Other: 1
Total: 4

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.