DISPOSABLE HME/FILTER— 510(k) K954194

Substantially Equivalent

Engstrom Medical

FDA 510(k) clearance K954194 for DISPOSABLE HME/FILTER, Substantially Equivalent on 1995-10-20. Applicant: Engstrom Medical. Device class: 1.

Clearance details

Applicant: Engstrom Medical
Product code: Code BYD
Device class: Class 1
Regulation: 21 CFR 868.5375
Advisory panel: Anesthesiology
Date received: 1995-09-06
Decision date: 1995-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sturgis, MI, US

Download summary PDF View on FDA.gov ↗

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K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE1995-08-25
K953540 — EEE1995-08-25

More clearances from Engstrom Medical

K954197 — DISPOSABLE FLEX TUBE1995-10-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.