I.V. SENTRY ALARM DEVICE— 510(k) K802101

Substantially Equivalent

Pike Medical Co.

FDA 510(k) clearance K802101 for I.V. SENTRY ALARM DEVICE, Substantially Equivalent on 1980-09-16. Applicant: Pike Medical Co.. Device class: 2.

Clearance details

Applicant: Pike Medical Co.
Product code: Code FLN
Device class: Class 2
Regulation: 21 CFR 880.2420
Advisory panel: General Hospital
Date received: 1980-09-03
Decision date: 1980-09-16
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.