FDA 510(k)

ULTRASONIC MEDICAL DEVICE MODEL 3 LO 4

K-Number: K827708 · 1983-04-12

Decision Date1983-04-12

Product Code

DecisionSubstantially Equivalent

Device Summary

ULTRASONIC MEDICAL DEVICE MODEL 3 LO 4 is the device name listed in this FDA 510(k) record. The listed applicant is Sterisson. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K827708. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASONIC MEDICAL DEVICE MODEL 3 LO 4?

ULTRASONIC MEDICAL DEVICE MODEL 3 LO 4 is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Sterisson. The 510(k) number is K827708.

When did ULTRASONIC MEDICAL DEVICE MODEL 3 LO 4 receive FDA 510(k) clearance?

ULTRASONIC MEDICAL DEVICE MODEL 3 LO 4 received FDA 510(k) clearance on 1983-04-12, under 510(k) number K827708.

Who is the listed applicant for ULTRASONIC MEDICAL DEVICE MODEL 3 LO 4?

The FDA 510(k) record lists Sterisson as the applicant. This does not by itself establish the device manufacturer.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.