K828586Substantially Equivalent

Entrekin Model Dx-300 Continuous Wave Ultrasonic Doppler Transducer

Name: K828586 Entrekin Model Dx-300 Continuous Wave Ultrasonic Doppler Transducer
Creator: Cranbury Medical Labs, Inc.
Published: 1982-12-14
License: https://open.fda.gov/license/

Cranbury Medical Labs, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K828586 is the FDA 510(k) clearance record for ENTREKIN MODEL DX-300 CONTINUOUS WAVE ULTRASONIC DOPPLER TRANSDUCER, cleared for Cranbury Medical Labs, Inc. on 1982-12-14. FDA records list 7 510(k) clearances for Cranbury Medical Labs, Inc., from 1982-01-28 to 1982-12-14. As of 2026-09-10, FDA records show no recalls naming K828586.

Clearance record

Decision date: 1982-12-14
Received: 1982-11-23 (21 days to decision)
Review panel: Unknown
Applicant: Cranbury Medical Labs, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No