NARCO AIR-SHEILDS SYS. 100 MONITOR SYS— 510(k) K802800

Name: FDA 510(k) clearance K802800
Creator: U.S. Food and Drug Administration
Published: 1980-11-24

Substantially Equivalent

Narco Air-Shields

FDA 510(k) clearance K802800 for NARCO AIR-SHEILDS SYS. 100 MONITOR SYS, Substantially Equivalent on 1980-11-24. Applicant: Narco Air-Shields. Device class: 2.

Clearance details

Applicant: Narco Air-Shields
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1980-11-06
Decision date: 1980-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K802126 — ISOLETTE INCUBATOR C-1001980-09-26
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Data sourced from openFDA. This site is unofficial and independent of the FDA.