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)

FLOWLOCK OXYGEN METER

K-Number: K811162 · 1981-05-08

ApplicantLifeguard Medical Products, Inc.
Decision Date1981-05-08
Product CodeBYJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLOWLOCK OXYGEN METER is the device name listed in this FDA 510(k) record. The listed applicant is Lifeguard Medical Products, Inc.. It received FDA 510(k) clearance on 1981-05-08 under 510(k) number K811162. The device is classified under product code BYJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOWLOCK OXYGEN METER?

FLOWLOCK OXYGEN METER is a medical device that received FDA 510(k) clearance on 1981-05-08. The listed applicant is Lifeguard Medical Products, Inc.. The 510(k) number is K811162.

When did FLOWLOCK OXYGEN METER receive FDA 510(k) clearance?

FLOWLOCK OXYGEN METER received FDA 510(k) clearance on 1981-05-08, under 510(k) number K811162.

Who is the listed applicant for FLOWLOCK OXYGEN METER?

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

What is the FDA product code for FLOWLOCK OXYGEN METER?

The FDA product code for FLOWLOCK OXYGEN METER is BYJ.

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 Lifeguard Medical Products, 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.

K013421LIFEGUARD NASAL CPAP MASK AND ACCESSORIESK915296MONOPOLAR ELECTRODEK920471LEVY ARTICULATING RETRACTORK915505REGULATOR FLOWMETERK915297TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MMK915298SUCTION/IRRIGATION CANNULA; CATLOG #532.00

View all 12 devices →

Related Devices (Code: BYJ)

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.

K130068DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)Essex Industries, Inc. D/B/A Essex Cryogenics of MK113767MOUNTED MEDICAL OXYGEN SYSTEMEssex Industries, Inc.K103324PRECISION LIQUID OXYGEN SYSTEMPrecision Medical, Inc.K101272MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3Essex Industries, Inc.K081779GOLOX-93Respironics, Inc.K080023MODIFICATION TO: SPIRITCaire, 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.

↑