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)

CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV

K-Number: K840313 · 1984-02-04

ApplicantImm Enterprises , Ltd.
Decision Date1984-02-04
Product CodeBWB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV is the device name listed in this FDA 510(k) record. The listed applicant is Imm Enterprises , Ltd.. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K840313. The device is classified under product code BWB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV?

CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Imm Enterprises , Ltd.. The 510(k) number is K840313.

When did CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV receive FDA 510(k) clearance?

CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV received FDA 510(k) clearance on 1984-02-04, under 510(k) number K840313.

Who is the listed applicant for CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV?

The FDA 510(k) record lists Imm Enterprises , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV?

The FDA product code for CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV is BWB.

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 Imm Enterprises , Ltd. 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.

K840311CAT. 7-EAR, NOSE & THROAT DEVICESK841386KOLLMANN URETHRAL DILATORK841387WESTON RECTAL SNAREK840304CATEGORY 17-MICROBIOLOGY DEVICESK840318CAT. 14-CLINICAL TOXIOLOGY DEVICESK840305CATEGORY 1 CIRCULATORY SYSTEM DEVICE

View all 52 devices →

Related Devices (Code: BWB)

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.

K884584TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADSEastmed Enterprises, Inc.K880318ROVENSTEIN FORCEPSEastmed Enterprises, Inc.K880319MAGILL FORCEPSEastmed Enterprises, Inc.K834169OP-CON SURGICAL INSTRUMENT #9Imm Enterprises , Ltd.K820451INTRODUCER FOR ENDOTRACHEAL TUBEImed 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.

↑