PCS-5 ACCESSORIES— 510(k) K812766

Name: FDA 510(k) clearance K812766
Creator: U.S. Food and Drug Administration
Published: 1981-12-17

Substantially Equivalent

Timeter Instrument Corp.

FDA 510(k) clearance K812766 for PCS-5 ACCESSORIES, Substantially Equivalent on 1981-12-17. Applicant: Timeter Instrument Corp.. Device class: 2.

Clearance details

Applicant: Timeter Instrument Corp.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1981-10-05
Decision date: 1981-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Timeter Instrument Corp.

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K875075 — RT-200 COMPUTER INTERFACE1988-04-21
K875074 — VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM20001988-02-22
K871603 — CRITERION II & IIA OXYGEN CONCENTRATORS1987-08-13
K864836 — L.A.P. SPIROMETER1987-03-06
K834274 — CRITERION I1984-04-13

Adverse events under product code BTI

product code BTI

Death: 25
Malfunction: 1,168
Total: 1,193

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.