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)

SOLO-SPHERE HEATER

K-Number: K760845 · 1976-10-27

ApplicantRespiratory Therapy
Decision Date1976-10-27
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SOLO-SPHERE HEATER is the device name listed in this FDA 510(k) record. The listed applicant is Respiratory Therapy. It received FDA 510(k) clearance on 1976-10-27 under 510(k) number K760845. 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 SOLO-SPHERE HEATER?

SOLO-SPHERE HEATER is a medical device that received FDA 510(k) clearance on 1976-10-27. The listed applicant is Respiratory Therapy. The 510(k) number is K760845.

When did SOLO-SPHERE HEATER receive FDA 510(k) clearance?

SOLO-SPHERE HEATER received FDA 510(k) clearance on 1976-10-27, under 510(k) number K760845.

Who is the listed applicant for SOLO-SPHERE HEATER?

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

What is the FDA product code for SOLO-SPHERE HEATER?

The FDA product code for SOLO-SPHERE HEATER 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

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.

↑