MODEL 533 PHOTOTHERAPY UNIT— 510(k) K810953

Substantially Equivalent

Narco Air-Shields

FDA 510(k) clearance K810953 for MODEL 533 PHOTOTHERAPY UNIT, Substantially Equivalent on 1981-04-23. Applicant: Narco Air-Shields. Device class: 2.

Clearance details

Applicant: Narco Air-Shields
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 1981-04-07
Decision date: 1981-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Narco Air-Shields

K820114 — SYSTEM V.HEART RATE/RESPIR. RATE MONIT.1982-02-12
K810474 — PROBE COVER1981-03-31
K802800 — NARCO AIR-SHEILDS SYS. 100 MONITOR SYS1980-11-24
K802126 — ISOLETTE INCUBATOR C-1001980-09-26
K792592 — AMBU UNIVERSAL SUCTION PUMP1980-01-11

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