Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ADDI-MIST

K-Number: K760964 · 1976-12-09

ApplicantRespiratory Care, Inc.
Decision Date1976-12-09
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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 1976-12-09 under 510(k) number K760964. 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 ADDI-MIST?

ADDI-MIST is a medical device that received FDA 510(k) clearance on 1976-12-09. The listed applicant is Respiratory Care, Inc.. The 510(k) number is K760964.

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

ADDI-MIST received FDA 510(k) clearance on 1976-12-09, under 510(k) number K760964.

Who is the listed applicant for 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 ADDI-MIST?

The FDA product code for ADDI-MIST is CAF.

Other records listing Respiratory Care, Inc. 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.

K892230RCI VIRAL/BACTERIAL FILTERK884150MODIFIED CONCHATHERM III CONTROLLED HEATERK881625CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLLK864147AQUAVALVEK863955COLBY LEVEL ALARMK861555CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT

View all 26 devices →

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.

K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd.K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)Joytech Healthcare Co. , Ltd.

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.

↑