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)

ENGSTROM EMMA ANESTHETIC GAS MONITOR

K-Number: K802614 · 1981-01-07

ApplicantLkb Instruments, Inc.
Decision Date1981-01-07
Product CodeCBS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENGSTROM EMMA ANESTHETIC GAS MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Lkb Instruments, Inc.. It received FDA 510(k) clearance on 1981-01-07 under 510(k) number K802614. The device is classified under product code CBS. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENGSTROM EMMA ANESTHETIC GAS MONITOR?

ENGSTROM EMMA ANESTHETIC GAS MONITOR is a medical device that received FDA 510(k) clearance on 1981-01-07. The listed applicant is Lkb Instruments, Inc.. The 510(k) number is K802614.

When did ENGSTROM EMMA ANESTHETIC GAS MONITOR receive FDA 510(k) clearance?

ENGSTROM EMMA ANESTHETIC GAS MONITOR received FDA 510(k) clearance on 1981-01-07, under 510(k) number K802614.

Who is the listed applicant for ENGSTROM EMMA ANESTHETIC GAS MONITOR?

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

What is the FDA product code for ENGSTROM EMMA ANESTHETIC GAS MONITOR?

The FDA product code for ENGSTROM EMMA ANESTHETIC GAS MONITOR is CBS.

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 Lkb Instruments, 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.

K8740941205 BETAPLATE LIQUID SCINTILLATION COUNTERK872955DELFIA(TM) FERRITIN KITK871303DELFIA(TM) THYROXINE (T4) KITK871599DELFIA(TM) HIGE KITK871644DELFIA (TM) HTSH KITK864452DELFIA(TM) TRIIODOTHYRONINE (T3) KIT

View all 52 devices →

Related Devices (Code: CBS)

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.

K974903GAS MODULE II, MODEL 0998-00-0143Datascope Corp.K953795VITALMAX 4100Pace Tech, Inc.K960490AS/3 COMPACT AIRWAY MODULE M-CAIOVDatex Medical Instrumentation, Inc.K951366RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)Riken Keiki Co., Ltd.K950101RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITORMarquette Electronics, Inc.K943458AS/3 AIRWAY MODULEDatex Division Instrumentarium Corp.

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.

↑