RESPIRATORY BLOWER— 510(k) K761294

Name: FDA 510(k) clearance K761294
Creator: U.S. Food and Drug Administration
Published: 1977-01-03

Substantially Equivalent

Harris-Lake, Inc.

FDA 510(k) clearance K761294 for RESPIRATORY BLOWER, Substantially Equivalent on 1977-01-03. Applicant: Harris-Lake, Inc.. Device class: 2.

Clearance details

Applicant: Harris-Lake, Inc.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1976-12-21
Decision date: 1977-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Harris-Lake, Inc.

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K761293 — RESPIRATORY HUMIDIFIER1977-01-03
K761295 — RESP. AIR TEMP. CONTROL & HAZARD MON.1976-12-30
K760333 — JAR, COLLECTOR FOR SUCTION SYSTEMS1976-10-27
K760314 — FLOWMETER, OXYGEN1976-08-04
K760316 — REGULATORS, LOW SUCTION1976-08-04

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.