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FDA 510(k)

GENTLEHALER(R)

K-Number: K892117 · 1989-06-23

ApplicantSchering Research
Decision Date1989-06-23
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GENTLEHALER(R) is the device name listed in this FDA 510(k) record. The listed applicant is Schering Research. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K892117. The device is classified under product code CCQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTLEHALER(R)?

GENTLEHALER(R) is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Schering Research. The 510(k) number is K892117.

When did GENTLEHALER(R) receive FDA 510(k) clearance?

GENTLEHALER(R) received FDA 510(k) clearance on 1989-06-23, under 510(k) number K892117.

Who is the listed applicant for GENTLEHALER(R)?

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

What is the FDA product code for GENTLEHALER(R)?

The FDA product code for GENTLEHALER(R) is CCQ.

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Related Devices (Code: CCQ)

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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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