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FDA 510(k)

ROTATOR, FIXED SPEED

K-Number: K760467 · 1976-10-29

ApplicantLederle Laboratories
Decision Date1976-10-29
Product CodeJQC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROTATOR, FIXED SPEED is the device name listed in this FDA 510(k) record. The listed applicant is Lederle Laboratories. It received FDA 510(k) clearance on 1976-10-29 under 510(k) number K760467. The device is classified under product code JQC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTATOR, FIXED SPEED?

ROTATOR, FIXED SPEED is a medical device that received FDA 510(k) clearance on 1976-10-29. The listed applicant is Lederle Laboratories. The 510(k) number is K760467.

When did ROTATOR, FIXED SPEED receive FDA 510(k) clearance?

ROTATOR, FIXED SPEED received FDA 510(k) clearance on 1976-10-29, under 510(k) number K760467.

Who is the listed applicant for ROTATOR, FIXED SPEED?

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

What is the FDA product code for ROTATOR, FIXED SPEED?

The FDA product code for ROTATOR, FIXED SPEED is JQC.

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Other records listing Lederle Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K770975ANTI-CONVULSANT DRUG CONTROLK770307MICRO/PETTOR, SMI

Related Devices (Code: JQC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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