FDA 510(k), K061993, EQUIVITAL, MODEL EQ-01

FDA 510(k), K061993, EQUIVITAL, MODEL EQ-01

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510(K) Number: K061993
Device Name: EQUIVITAL, MODEL EQ-01
Manufacturer: JUSTIN PISANI
Device Classification Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation Number: MHX
Classification Product Code: KXA
Date Received: 07/14/2006
Decision Date: 11/03/2006
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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