HOME AMB-ALERT— 510(k) K934344

Substantially Equivalent

Medway

FDA 510(k) clearance K934344 for HOME AMB-ALERT, Substantially Equivalent on 1994-04-29. Applicant: Medway. Device class: 1.

Clearance details

Applicant: Medway
Product code: Code KMI
Device class: Class 1
Regulation: 21 CFR 880.2400
Advisory panel: General Hospital
Date received: 1993-09-08
Decision date: 1994-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, TN, US

Download summary PDF View on FDA.gov ↗

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