MODEL 100 SPECTRAVIEW— 510(k) K800655

Substantially Equivalent

Edwards Laboratories

FDA 510(k) clearance K800655 for MODEL 100 SPECTRAVIEW, Substantially Equivalent on 1980-04-16. Applicant: Edwards Laboratories. Device class: 1.

Clearance details

Applicant: Edwards Laboratories
Product code: Code DQC
Device class: Class 1
Regulation: 21 CFR 870.2390
Advisory panel: Cardiovascular
Date received: 1980-03-25
Decision date: 1980-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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More clearances from Edwards Laboratories

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K792034 — INTEGRAL DISPOSABLE HOLDER CARPENTIER1979-12-07
K790047 — CARDIAC OUTPUT COMPUTER, MDEL 9520A1979-02-26
K790022 — DISPOSABLE HOLDER FOR BIOPROSTHESIS1979-01-15

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