NON-INVASIVE AMPLIFIER— 510(k) K810828

Substantially Equivalent

Henry Ford Hospital

FDA 510(k) clearance K810828 for NON-INVASIVE AMPLIFIER, Substantially Equivalent on 1981-04-10. Applicant: Henry Ford Hospital. Device class: 2.

Clearance details

Applicant: Henry Ford Hospital
Product code: Code DRR
Device class: Class 2
Regulation: 21 CFR 870.2050
Advisory panel: Cardiovascular
Date received: 1981-03-24
Decision date: 1981-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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