FDA 510(k)

OPTISON ULTRASONIC SCALER

K-Number: K837382 · 1983-05-06

Decision Date1983-05-06

Product Code

DecisionSubstantially Equivalent

Device Summary

OPTISON ULTRASONIC SCALER is the device name listed in this FDA 510(k) record. The listed applicant is Pelton & Crane Co.. It received FDA 510(k) clearance on 1983-05-06 under 510(k) number K837382. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTISON ULTRASONIC SCALER?

OPTISON ULTRASONIC SCALER is a medical device that received FDA 510(k) clearance on 1983-05-06. The listed applicant is Pelton & Crane Co.. The 510(k) number is K837382.

When did OPTISON ULTRASONIC SCALER receive FDA 510(k) clearance?

OPTISON ULTRASONIC SCALER received FDA 510(k) clearance on 1983-05-06, under 510(k) number K837382.

Who is the listed applicant for OPTISON ULTRASONIC SCALER?

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

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Official Source

View on FDA Database →

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