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)

PEAK FLOWMETERS FOR SPIROMETRY

K-Number: K851265 · 1985-10-29

ApplicantSolcoor, Inc.
Decision Date1985-10-29
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEAK FLOWMETERS FOR SPIROMETRY is the device name listed in this FDA 510(k) record. The listed applicant is Solcoor, Inc.. It received FDA 510(k) clearance on 1985-10-29 under 510(k) number K851265. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEAK FLOWMETERS FOR SPIROMETRY?

PEAK FLOWMETERS FOR SPIROMETRY is a medical device that received FDA 510(k) clearance on 1985-10-29. The listed applicant is Solcoor, Inc.. The 510(k) number is K851265.

When did PEAK FLOWMETERS FOR SPIROMETRY receive FDA 510(k) clearance?

PEAK FLOWMETERS FOR SPIROMETRY received FDA 510(k) clearance on 1985-10-29, under 510(k) number K851265.

Who is the listed applicant for PEAK FLOWMETERS FOR SPIROMETRY?

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

What is the FDA product code for PEAK FLOWMETERS FOR SPIROMETRY?

The FDA product code for PEAK FLOWMETERS FOR SPIROMETRY is BZH.

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 Solcoor, 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.

K882386AGAR 3K NEUROMUSCULAR STIMULATORK882387AGAR 4000 NEUROMUSCULAR STIMULATORK862454AGAR 7K TENS INSTRUMENTK861895UNI-TENSK861894AGAR 9K TENSK861896UNI-TENS XL TENS

View all 7 devices →

Related Devices (Code: BZH)

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.

K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife CorporationK252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd.K241338Peak Flow MeterChongqing Moffy Innovation Technology Co., Ltd.K232588Aluna 2Knox Medical DiagnosticsK230423Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd.K222810TD-7301 Peak Flow meterGostar 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.

↑