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FDA 510(k)

NEBULIZER, MICRO (ADDI-MIST)

K-Number: K760335 · 1976-08-11

ApplicantRespiratory Care, Inc.
Decision Date1976-08-11
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEBULIZER, MICRO (ADDI-MIST) is the device name listed in this FDA 510(k) record. The listed applicant is Respiratory Care, Inc.. It received FDA 510(k) clearance on 1976-08-11 under 510(k) number K760335. 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 NEBULIZER, MICRO (ADDI-MIST)?

NEBULIZER, MICRO (ADDI-MIST) is a medical device that received FDA 510(k) clearance on 1976-08-11. The listed applicant is Respiratory Care, Inc.. The 510(k) number is K760335.

When did NEBULIZER, MICRO (ADDI-MIST) receive FDA 510(k) clearance?

NEBULIZER, MICRO (ADDI-MIST) received FDA 510(k) clearance on 1976-08-11, under 510(k) number K760335.

Who is the listed applicant for NEBULIZER, MICRO (ADDI-MIST)?

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

What is the FDA product code for NEBULIZER, MICRO (ADDI-MIST)?

The FDA product code for NEBULIZER, MICRO (ADDI-MIST) is CAF.

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Related Devices (Code: CAF)

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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