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FDA 510(k)

METERED DOSE INHALER (MDI) SPACER

K-Number: K911807 · 1991-10-23

ApplicantHealth Products, Inc.
Decision Date1991-10-23
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

METERED DOSE INHALER (MDI) SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Health Products, Inc.. It received FDA 510(k) clearance on 1991-10-23 under 510(k) number K911807. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METERED DOSE INHALER (MDI) SPACER?

METERED DOSE INHALER (MDI) SPACER is a medical device that received FDA 510(k) clearance on 1991-10-23. The listed applicant is Health Products, Inc.. The 510(k) number is K911807.

When did METERED DOSE INHALER (MDI) SPACER receive FDA 510(k) clearance?

METERED DOSE INHALER (MDI) SPACER received FDA 510(k) clearance on 1991-10-23, under 510(k) number K911807.

Who is the listed applicant for METERED DOSE INHALER (MDI) SPACER?

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

What is the FDA product code for METERED DOSE INHALER (MDI) SPACER?

The FDA product code for METERED DOSE INHALER (MDI) SPACER is CAF.

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Related Devices (Code: CAF)

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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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