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)

VOLUMETRIC CONTROLLER

K-Number: K822216 · 1982-08-16

ApplicantQuest Medical, Inc.
Decision Date1982-08-16
Product CodeBTC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VOLUMETRIC CONTROLLER is the device name listed in this FDA 510(k) record. The listed applicant is Quest Medical, Inc.. It received FDA 510(k) clearance on 1982-08-16 under 510(k) number K822216. The device is classified under product code BTC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLUMETRIC CONTROLLER?

VOLUMETRIC CONTROLLER is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is Quest Medical, Inc.. The 510(k) number is K822216.

When did VOLUMETRIC CONTROLLER receive FDA 510(k) clearance?

VOLUMETRIC CONTROLLER received FDA 510(k) clearance on 1982-08-16, under 510(k) number K822216.

Who is the listed applicant for VOLUMETRIC CONTROLLER?

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

What is the FDA product code for VOLUMETRIC CONTROLLER?

The FDA product code for VOLUMETRIC CONTROLLER is BTC.

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 Quest Medical, 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.

K241058Lyka® PORT Needle Free Access Device (4170Y)K213846Q2 Blood Administration SetsK213588Q2 IV Administration SetsK202672Precision Delivery Infusion SetK201984MPS 3 ND Myocardial Protection SystemK200438MPS 3 Myocardial Protection System

View all 38 devices →

Related Devices (Code: BTC)

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.

K181424PeDIAPedia, LLCK940220REBREATHER BAGSZefon Medical ProductsK932584BREATHING BAGSMerit Medical Systems, Inc.K932496PRECISION MED PRODUCTS, LTD. BREATHING BAGSPrecision Med Products, Ltd.K932581BREATHING BAGSMed-Plastics Intl., Inc.K932191BREATHING BAGSLife Shield Healthcare Products, 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.

↑