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)

HALOTHANE VAPORIZER 950, ENFLURANE

K-Number: K841157 · 1984-06-07

ApplicantSiemens Elema AB
Decision Date1984-06-07
Product CodeCAD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HALOTHANE VAPORIZER 950, ENFLURANE is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Elema AB. It received FDA 510(k) clearance on 1984-06-07 under 510(k) number K841157. The device is classified under product code CAD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HALOTHANE VAPORIZER 950, ENFLURANE?

HALOTHANE VAPORIZER 950, ENFLURANE is a medical device that received FDA 510(k) clearance on 1984-06-07. The listed applicant is Siemens Elema AB. The 510(k) number is K841157.

When did HALOTHANE VAPORIZER 950, ENFLURANE receive FDA 510(k) clearance?

HALOTHANE VAPORIZER 950, ENFLURANE received FDA 510(k) clearance on 1984-06-07, under 510(k) number K841157.

Who is the listed applicant for HALOTHANE VAPORIZER 950, ENFLURANE?

The FDA 510(k) record lists Siemens Elema AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALOTHANE VAPORIZER 950, ENFLURANE?

The FDA product code for HALOTHANE VAPORIZER 950, ENFLURANE is CAD.

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 Siemens Elema AB 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.

K023354COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81EK010923KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392EK010925SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407EK002137CATHCOR DESKTOPK001315MODIFICATION TO KION ANESTHESIA SYSTEMK970839SERVO VENTILATOR 300A

View all 63 devices →

Related Devices (Code: CAD)

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.

K240375V80 Anesthetic Vaporizer (V80)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K172702Tec 820, Tec 850Datex-Ohmeda, Inc.K110608SEVOFLURANE VAPORIZER ADAPTORPiramal Critcal Care, Inc (Formerly Minrad, Inc)K060331SIGMA ALPHA VAPORIZERPenlon LimitedK053564KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454Penlon LimitedK051666GAV - GENERAL ANAESTHETIC VAPORIZERGeneral Anaesthetic Services Limited

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.

↑