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)

BE #16 - MANIFOLD

K-Number: K823481 · 1982-12-22

ApplicantInstrumentation Industries, Inc.
Decision Date1982-12-22
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BE #16 - MANIFOLD is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Industries, Inc.. It received FDA 510(k) clearance on 1982-12-22 under 510(k) number K823481. The device is classified under product code BZO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BE #16 - MANIFOLD?

BE #16 - MANIFOLD is a medical device that received FDA 510(k) clearance on 1982-12-22. The listed applicant is Instrumentation Industries, Inc.. The 510(k) number is K823481.

When did BE #16 - MANIFOLD receive FDA 510(k) clearance?

BE #16 - MANIFOLD received FDA 510(k) clearance on 1982-12-22, under 510(k) number K823481.

Who is the listed applicant for BE #16 - MANIFOLD?

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

What is the FDA product code for BE #16 - MANIFOLD?

The FDA product code for BE #16 - MANIFOLD is BZO.

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 Instrumentation Industries, 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.

K180510NS 120P-TRS Airway Pressure GaugeK162753RTC 26-C Inline Aerosol AdapterK113644PILOT TUBE REPAIR KITK102127ENDOTRACHEAL TUBE CHANGERSK101857RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-VK091111RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC

View all 45 devices →

Related Devices (Code: BZO)

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.

K953784UNICOR, INC. CORRUGATED TUBINGUnicor, Inc.K953785UNICOR, INC. VENTILATOR HOSESUnicor, Inc.K952011PRIMA BREATHING BAGSPrima, Inc.K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.K952010PRIMA VENTILATOR HOSESPrima, Inc.K952012PRIMA CUSTOM ANESTESIA CIRCUITPrima, Inc.

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.

↑