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)

SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)

K-Number: K961476 · 1996-07-16

ApplicantSalter Labs
Decision Date1996-07-16
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 1996-07-16 under 510(k) number K961476. 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 SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)?

SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) is a medical device that received FDA 510(k) clearance on 1996-07-16. The listed applicant is Salter Labs. The 510(k) number is K961476.

When did SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) receive FDA 510(k) clearance?

SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) received FDA 510(k) clearance on 1996-07-16, under 510(k) number K961476.

Who is the listed applicant for SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)?

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

What is the FDA product code for SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)?

The FDA product code for SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) is CAF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Salter Labs 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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)K161719Salter Labs Bubble HumidifierK151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/NasalK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaK151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesK092685PNEUMOTHERML, MODEL: 5800

View all 47 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.

↑